Free Webinar: The Insider's Guide to CTMS for Investigators

Posted by Greg Pack on Dec 6, 2016 9:49:42 AM
What is it like to use the industry's first (and still best) CTMS? Here's your chance to find out. 

22 years.  1,600 investigative sites. 10,000 users. 30,000 + studies. 80 countries. 

Why is our CTMS so popular? AI-CTMS_HOMEPAGE_ICONS-CONFIDENCE.png

To answer that question, you have to experience it for yourself. 

At our free webinar, "The Insider's Guide to CTMS for Investigators," you'll see the platform in action, including the actual interface. You'll learn exactly how CTMS for Investigators streamlines the study management process, helping you organize and centralize your research and manage virtually every study detail with ease.

Click the image below to get to our registration page!

Register Now!

Topics: ctms, Site Solutions Summit 2016

Introducing "My Clinical Diary": A NEW Mobile ePRO App

Posted by Dianne Chatterton on Nov 11, 2016 3:29:15 PM
eClinicalOS introduces mobile app to help you connect better with patients 

No matter how well-designed a trial may be, if study subjects find it hard or inconvenient to log their data, its success is in doubt.MY CLINICAL DIARY - WELCOME

The growth of electronic patient-reported outcomes (ePRO) technology has been a boon to researchers, helping increase efficiency, improve compliance and gather more accurate data. But not every patient can or wants to access a website on a computer every time they need to log a report.

That’s why we’re so excited to announce the launch of
 My Clinical Diarya new mobile app that lets study participants log their data from any iOS-enabled smartphone with web access. Fully integrated into the eClinicalOS (eCOS) platform, the app streamlines how you collect and manage patient study data. 

My Clinical Diary Mobile AppMy Clinical Diary is a native app, meaning it works like a true mobile app and not just a web page disguised to fit inside a mobile browser. It’s available for iPhones through the Apple App Store, and an Android version is scheduled for release in early 2017.


Click below to learn more about how the My Clinical Diary app can help you improve your study process and outcomes.

  My Clinical Diary  

Topics: ePro, mobile, electronic patient reported outcomes, mobile app

Register Now: "The Insiders Guide to CTMS" Webinar Nov 16th!

Posted by Greg Pack on Nov 11, 2016 2:20:02 PM
What is it like to use the industry's first (and still best) CTMS? Here's your chance to find out. 

22 years.  1,600 investigative sites. 10,000 users. 30,000 + studies. 80 countries. 

The Insider's Guide to CTMS webinarWhy is our CTMS so popular? 

To answer that question, you have to experience it for yourself. 

At our free webinar, "The Insider's Guide to CTMS for Investigators," you'll see the platform in action, including the actual interface. You'll learn exactly how CTMS for Investigators streamlines the study management process, helping you organize and centralize your research and manage virtually every study detail with ease. 

Ready to sign up? Just Click the link below!

Register Now!

We look forward to seeing you there! 

 

Watch Now: How to Implement the Central Monitor Role in Your RBM Trial

Posted by Amy Young on Aug 23, 2016 2:33:40 PM

Thursday, Sept, 8 2016 

The eClinicalOS-Remarque RBM solution is a powerful tool that can help optimize your workflows. But what about your internal processes? Watch our free webinar to find out more about the increasingly popular practice of central monitoring.

Remarque-RBM-logo.jpgRisk-Based Monitoring is the hottest trend in clinical trials since, well, EDC! No doubt about it, RBM technology (like ours) can be transformative. But to be truly successful, you need to look at your overall processes, too.

Watch Webinar Now!

While there are many different ways to organize your team and establish responsibilities, many organizations are creating a "Central Monitor" role to ensure the efficient coordination of data review, signal identification, and follow-up action.  In this webinar, we'll demonstrate how to create an effective flow between the Central Monitor, the site monitors (CRAs) and other team members responsible for reviewing data.

Topics: Risk-Based Monitoring

eClinicalOS Helps South African Researchers Learn About New Data Technology

Posted by Amy Young on Aug 2, 2016 5:00:00 AM

Last year, eClinicalOS leaders traveled to South Africa tsouth_africa.jpgo explore new territories for our clinical data solutions. The trip was a great success – even capturing the attention of industry publication Clinical Leader (read the story here.) This year, we're deepening our commitment to the region through an expanded partnership with SACRA (South African Clinical Research Association).

In 2015, our team attended a SACRA event where we discussed the challenges and opportunities of the coming wave of big data.

In 2016, all eyes are on cognitive technology.

On 22 July, we had the opportunity to participate in SACRA's Cape Town breakfast meeting, at which our Regional Sales Lead, Simon Hawken, presented via videoconference.

Sacra.jpgSACRA attendees, gathered for the July meeting


Simon's talk centered on how IBM Watson Health's cognitive technology can turn big data into knowledge and actionable insights that the human brain could never compute.

Screen_Shot_2016-07-29_at_11.35.12_AM.png
This slide from Simon's presentation outlines some of the global challenges in health care.


“Already, even at the micro level of clinical trial software technologies such as eClinicalOS, the ‘Watson effect’ is having an impact on what we are developing and what new capabilities we will be able to bring to market to support our clients,” said Mr. Hawken. “This will make a significant difference to all stakeholders in health care and life sciences – but the people who will benefit most will be patients.”

Louise Marais, SACRA Cape Town representative, was pleased with the event. "With South Africa being a third world country, Simon's talk was extremely informative to our audience," she said. "Development of new technology within clinical trials is vital to our industry as it has proven to be the way forward."

This September, the eClinical division will be supporting the 7th annual SACRA conference as a Platinum Sponsor.  At the Bytes Conference Centre in Midrand on 8-9 September, you’ll find us at Booth #9.

Also at the September conference, IBM Watson Health's Vice President for Go To Market Transformation, Zaher El-Assi, will be speaking. Zaher's presentation will build on Simon's talk to explore how cognitive systems that understand, reason and learn can transform the practice of clinical research. He'll demonstrate how South African researchers can incorporate these and similar technologies into their clinical studies and dramatically enhance overall performance, efficiency and outcomes.

If you would like to arrange a meeting at the show, you can contact us here.

Topics: clinical trials, South Africa, clinical systems, cognitive technology

IntroWebinar: "Building Your First Study in eClinicalOS" (Recording)

Posted by Amy Young on Aug 1, 2016 2:58:12 PM

"Building Your First Study in eClinicalOS"

Thursday, 17 August at 10 a.m. AEST (Australian Eastern Standard Time)

With eClinicalOS, anyone can learn to build a study. Join us to learn more! 

At eBuiding Your First Study in eClinicalOS Webinar RegistrationClinicalOS, we're all about self-sufficiency. Our platform has been designed to give you, the end user, as much control as possible over your research. That's why we offer you a choice not only in how you build your study, but also who builds it and when you deploy. 

If you're more the do-it-yourself type, join our webinar on 17 August for tips on setting up your first study in the eCOS system. Watch as we build a basic EDC study – from scratch – in under an hour. Our intuitive, point-and-click user experience makes the process easy and seamless! 

Register Here!

Note: This event is scheduled to be convenient for those in Asia/Pacific time zones. In a different location? Convert your time zone here.

eClinicalOS v2016.6.0 Release Introduces NEW Smart Reporting Module

Posted by Amy Young on Jul 19, 2016 9:30:00 AM

Latest release also includes a new training tool called WalkME and enhancements to user interface

coffee-desk-laptop-notebook.jpgAttention all eCOS users! The release of eClinicalOS v2016.6.0 will occur on Friday, July 29, 2016 between 8:00 pm and 11:00 pm EDT (to reduce potential impact to studies). There will be 3 hours of downtime while the upgrade is made.

This release contains some exciting new enhancements to the platform. Read on for more details.

NEW Smart Reports Module

No matter how strong your electronic data capture (EDC) system, how experienced your team or how well-designed your trial, the study will fall short of success if the data can’t be thoroughly analyzed, reported and interpreted.

That’s where Smart Reports comes in.

Powered by SAS Visual Analytics (VA), the new Smart Reports module creates single-study and cross-study reports that help you draw better visual and logical conclusions across data sets. Even better, you can do it all without leaving eClinicalOS, because Smart Reports is fully integrated into the platform. With a single sign-on, you can harness the power of SAS VA without having to leave eCOS and export data back into it. The Smart Reports data warehouse refreshes the system every 30 minutes, giving you valuable insights into all of your clinical data, metadata and audit-trail data. Plus, customized role permissions help ensure that the right EDC users have access to the right reports.

Learn more about Smart Reports here.

Smart_Reports_Chart.png

WalkMe Training Tool Integration

WalkMe is a library of guided software tutorials. Each online tour provides navigation advice and practical examples of commonly-performed tasks in the EDC.

WalkME sits on top of eClinicalOS in order to guide users through tasks in the system. During the tour, a pop-up window with text describes a navigation step, and when the user clicks the 'Next' button, the next screen in the sequence appears.

The tool also allows Merge to supply your study with any newly added WalkMe tutorials  based on the modules that are relevant to your study. For example, if a new tutorial has been created for Endpoint Adjudication, and EAM is enabled in your study, you will get a notification about the updated training the next time you log in.

WalkME is great for training and can be revisited anytime you want to refresh your knowledge. Contact your account manager to find out how to get WalkME for your users. 

WalkMe_Screenshot.png

User Interface Updates

Several areas of the system are being updated to create a consistent look and feel across eClinicalOS. These changes do not impact functionality, and will be most notable on the Team and EDC Landing Pages, Medical Coding, and My Profile.


Need assistance?

If you have questions or concerns about the impact of the update on your studies, please contact our technical support team (available 24/7/365).

• Email: support@eclinicalos.com 
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need a demo?

If you would like a brief demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com.

Topics: Release Notes, Merge eClinical, clinical research, training, smart reporting

You (yes, YOU) can learn to build a clinical study in an EDC platform

Posted by Amy Young on Jul 15, 2016 10:56:10 AM

You don't need months and months of training to set up a study in eClinicalOS. Attend our free webinar and learn why.

Learn the Screts of Building a Study on or July 20 webinar

Building the framework for a study in a cloud-based electronic data capture (EDC) platform used to be difficult and time-consuming. Those days are over, thanks to eClinicalOS. With our easy-to-use interface, anyone on your team can learn to build a clinical study, in record time.

You're invited to see exactly how easy and straightforward our build process is at a free webinar, "The Secrets to Building a Study" on Wednesday, July 20th at 12 p.m. EDT.

During the presentation, we'll walk through the steps of a basic build and create an actual study – from scratch! – in under an hour.  

Afterwards, you can request a free Sandbox account (if you haven't already) and see what it's like to use the system in a real-world environment, on your own time.

We hope to see you on July 20th! Just click below to register. 

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Topics: EDC, clinical research, clinical data management

Going to DIA? See eClinicalOS in Action at Booth 607

Posted by Amy Young on Jun 20, 2016 10:00:00 AM

DIA-2.jpg

With 7,500+ attendees and 450+ exhibits, DIA is one of the largest gatherings of life science professionals in the world. With so much going on, you have to plan ahead to manage your time wisely. So we thought we'd help you out by sharing our list of events (Booth #607– just look for the big sign!).

Each day of the show, we'll be offering demonstrations of some of the most popular features in our Electronic Data Capture & Management platform, including some exciting new additions you won't want to miss. Check out the schedule below and make plans to stop by!

Monitor Management & Targeted SDV
Digital tools to help site monitoring teams work more efficiently
9:15 – 9:45 a.m. and 1:15 – 1:45 p.m.

Risk Based Monitoring
Signal-driven RBM integrated into our EDC helps you take action on risks, sooner
10:15 – 10:45 a.m. and 2:15 – 2:45 p.m.

Smart Reporting
Powerful analytics to help drive better decisions
11:15 – 11:45 a.m.

ePRO
Get the patient perspective: Collect data from subjects anywhere, anytime
12:15 – 12:45 p.m.

Endpoint Adjudication
Paperless workflow saves time and enhances communication
3:15 – 3:45 p.m.

Data Migration
Migrate study data to our platform effortlessly – even mid-trial
4:15 – 4:45 p.m. (Monday and Tuesday only)

Schedule my demo!

Unless otherwise noted, all demos take place every day, June 27 – 29, at Booth #607.

None of these times work for you? Sign up here for a personal demo (of any of our products, including our core EDC) and a representative will email you to arrange a meeting. If you have any questions, please reach out to our Director of Inside Sales, Bruce Avery, at bavery@us.ibm.com.

See you in Philly!

Merge eClinical Marketing Team

 

Topics: EDC, clinical research, DIA

Learn How to Design a Study with Targeted SDV

Posted by Amy Young on May 20, 2016 2:04:28 PM
Targeted SDV in eClinicalOS By narrowing your monitoring focus, you can improve overall operations.

Last month, we presented a webinar highlighting one of our new modules: Monitor Management (View the recording here). (And by the way, it was one of our highest-attended webinars of all time!)

Our next webinar also promises to be very popular. On Tuesday May 24th, we will cover Monitoring Levels, another new feature in eClinicalOS. Monitoring Levels is a targeted source data verification (SDV) tool that helps reduce the clinical monitoring burden without compromising data quality.

Industry experts agree – 100% SDV has little impact on the quality of data in any clinical trial. So it only makes sense to target your monitoring to the areas and activities that pose the highest level of risk.

With Monitoring Levels, a variety of targeted SDV plans can be designed using criteria like site performance, analyzed risk, or even geography. Individual sites and subjects can be assigned to a monitoring level, thereby creating a customized, reduced SDV strategy for each study.

At our webinar on May 24th, product director Sebastien Bohn will take you inside the eClinicalOS platform and demonstrate how you can use these features to your advantage in your next study. After his presentation, ample time will be allotted for questions and answers.

Click below to sign up now!

5.24 How to design a Study with Targeted SDV

 

 

Topics: EDC, clinical trials, SDV

Does Social Media Have a Place in Clinical Trials?

Posted by Amy Young on May 6, 2016 1:30:00 PM

Many Experts Say Yes! (But Caution is Key.)

Social Media has utterly transformed our day-to-day lives. With a few taps on a keyboard, weman-field-smartphone-yellow-large.jpg can follow global brands, keep up with our favorite sports stars or discover something new through a hashtag. Our smartphones and laptops give us access to the world, so why wouldn't we use them in clinical trials?

Risks v Rewards
Clinical professionals have historically shied away from social media – and that's for good reason. Regulations figure large in our industry, and how do you regulate something you can't control?  No doubt about it, social media carries tremendous potential to expose sites, CROs, and especially sponsors to regulatory, financial and reputational risks. But more and more, organzations are working through these risks in order to reap the rewards.

Transforming Patient Recruitment
A recent analysis found that only 6% of trials are completed on time, and 8% were delayed by at least one month due to low enrollment. Adding to that, between 15-20% of trials never enroll a single patient, wasting time, funds and other resources. What’s causing this? Part of the problem is a lack of patient awareness about clinical trials – and the old standbys like posters, newspaper ads, flyers, referral letters, and radio spots aren’t quite cutting it.

As many are finding out, social media has the power to help you recruit the right subjects easily and efficiently – as long as you're smart about it. 

Global Experts Weigh In
Recently, Merge co-presented a webinar on social media in clinical trials with two subject matter experts based in Australia. Throughout the presentation, strategies and best practices were shared. Here are a few of their tips for safely utilizing social media in your research:

  • Include social media policy in patient consent forms to help guard against confidentiality breaches
  • Collect subjects’ social media IDs
  • Educate subjects on what they can and can’t post about (e.g mood, energy levels, pain levels, adverse effects)
  • Select the right channels for the right audience. The most popular social media channels in one country may be completely different in another.
  • Monitor performance and comments daily during campaigns. Make sure you have the systems and resources in place to manage comments and enquiries before you start.
  • Develop a crisis management plan for social media and regularly train staff

Want to learn more? Watch the recording of our webinar! Just click the button below to get access to "Social Media in Clinical Trials: Mitigate the Risks, Maximize the Benefits."

View Webinar Now

Topics: Merge eClinical, clinical research

New Features to Make Site Monitoring Easier & More Effective

Posted by Amy Young on Apr 19, 2016 10:40:06 AM

Clinical Site Monitoring is a critical, yet time-consuming (and often expensive) part of the study management process. The latest release of eClinicalOS (scheduled for April 29)  includes updates designed to address a number of monitoring challenges. These features, plus last month's release of our new module, Monitor Management, will help cut time, hassle, and unnecessary expense from the site monitoring process. Read on for details!

clinical site monitoring solutions


The NEW Optional Monitor Management Module

Now, site monitoring teams can focus on work, not paperwork

Last month's release of eClinicalOS featured a brand new module we call Monitor Management. This digital solution centralizes and organizes the work of clinical site monitoring for all team members, helping you save time and resources while getting more work done. Create site visit templates, see visit progress in handy charts, even communicate with your team via an embedded discussion channel – it's all there, all online. Email us at info@eclinicalos.com to get more information on the ways Monitor Management can help your team!


'Monitoring Level' Functionality:
Available with Release 2016.4.0 on 4/29

Implement advanced SDV strategies with just a few clicks

Source Document Verification (SDV) just got smarter! With the new Monitoring Level feature in eCOS you can design a variety of SDV plans based on site performance, analyzed risk, or even geography. You can then assign individual sites and subjects to a Monitoring Level, effectively implementing an advanced SDV strategy for your study. If you need to adjust the monitoring level during the course of the study, that's easy, too (and a record of those changes will be logged for auditing purposes). This feature will be available after the next release of eClinicalOS on April 29.


Customizable Field Indicators:
Available with Release 2016.4.0 on 4/29

Assign complex data verification actions with ease

Some studies may require more than one indicator of data-point verification. If you enable Customizable Field Indicators (CFI) after the next eCOS release, you will be able to create a custom label for your flagged item, provide the user with permissions to perform the new type of review, and configure the fields in page design that use the new flag. Best of all, the CFI does not replace SDV but can be used concurrently. Now you can report – at the field level – actions such as 'Medical Review', 'Critical Variable Checked' or any other variables that match your process. This feature will be available after the next release of eClinicalOS on April 29.

Topics: clinical sites, CRA, clinical site monitoring

More Executives Choose to Migrate Studies Off Questionable Data Platforms

Posted by Amy Young on Mar 28, 2016 1:50:26 PM

Are you concerned about the financial viability of your current EDC vendor? Perhaps you should be. 

 
MIGRATION.jpg
 
At eClinicalOS, we're used to customers switching to us after their current trials are finished. But recently, we've noticed a new trend – companies switching to our platform mid-study. 
 
One look at the media and it's easy to see why some are making the move: stories of mismanagement and poor financial performance at some vendors are unfortunately all-too common. 
 
But why are they choosing eClinicalOS?  We like to think it's because of our solid reputation, super-fast study build, and affordable pay-as-you-go model.  Our new customers also tell us it's because of these points:  
  • Financial stability
    Over the years, we've maintained stable executive leadership. And with our recent acquisition by IBM, we're now backed by one of the most powerful and successful companies in the world.  
  • Regulatory and operational best practices
    Our operating procedures and management practices are tested by more than 50 audits each year. Notably, we have never failed an audit!
  • Migration expertise
    We have unmatched experience in safely and efficiently migrating active clinical studies to our platform. 

What would you do if you lost all of your study data due to a failing vendor? Don't wait to find out. Contact us today to find out how you can protect your data by migrating it to our platform. Often, we can provide a quote in 24 hours or less.

Get my quote

 

Topics: EDC, eclinical systems, data migration

News: Society for Clinical Research Sites and Merge eClinical Announce Expanded Partnership

Posted by Amy Young on Mar 3, 2016 4:00:36 PM

newspaper.jpg

Ellicott City, M.D., March 1, 2016

The Society for Clinical Research Sites (SCRS), the global trade organization fully dedicated to representing the interests of clinical research sites, announced an expanded partnership with the eClinical division of Merge Healthcare, an IBM company. 

“We are pleased to have Merge’s support for a number of important initiatives and member programs,” said Christine Pierre, president of SCRS. “This level of partnership is symbolic of Merge’s deep commitment to creating a sustainable future for clinical research sites globally.”

As a Site Engagement Partner, Merge will continue to participate on the SCRS Global Impact Board at an executive level, and work closely with SCRS’ Leadership Council to determine strategic initiatives for SCRS.

Here at Merge, we are excited to announce this new partnership and look forward to working closely with SCRS this year! Look for us at the Asia-Pac Site Solutions Summit in Melbourne, Australia (July) and at the Global Site Solutions Summit in Boca Raton, Florida (October). Our CTMS team will be in attendance and would love to talk to you! 

About SCRS
SCRS is a global trade organization founded in 2012 which represents over 2,600 research sites in 42 countries. SCRS’ mission is to unify the voice of the global clinical research site community for greater site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites and the companies that sponsor or support the work conducted at clinical research sites will benefit from membership and partnership. Visit MySCRS.org.

Topics: Trade Shows, clinical sites, ctms

New Release: eClinicalOS v2016.2.0, Coming March 4

Posted by Sean Farres on Feb 18, 2016 12:02:00 PM

We are pleased to announce the release of Merge eClinicalOS v2016.2.0 on Friday, March 4, 2016.

eClinicalOS EDC eCRFThis release includes updates to the Advanced Expression Editor as well as some enhancements to existing tools.

Here are a few highlights of the upcoming release:

Expression Editor

Based on feedback, the 'power' operator available in the Basic editor was missing in the Advanced Expression Editor. Some expressions could be adjusted but other expressions were simply unavailable. With this release, the Power operator has been added to the Advanced Editor with both functionality to-a-constant (pow(3)) and to-a-value from a FieldValue (pow(T.C)).

Revision Moves for Site Management

Over time, tools to support revision moves in eClinicalOS have evolved. With the release of v2016.2.0, you will now be able to "batch move" subjects from one revision to another for multiple sites in a single job. This enables users who work on large studies to start the action and move on to other tasks while it completes.

Filters on EAM History Report (CSV)

Large reports, such as the EAM History Report (CSV), can fail based on the amount of information gathered and the limitations on the total number of cells per workbook in Excel. The initial filters did not provide all the options required by our users. With this release, the initial filters have been replaced with a set of three that can be used simultaneously to provide lots of combination filters. 

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: support@eclinicalos.com 
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, advanced expression editor, EDC, System Update, Update

Employing Millennials? You Need Up-to-Date eClinical Technology

Posted by Amy Young on Jan 18, 2016 10:00:00 AM

Millennials and Clinical Data Management Software and EDC

The "iGeneration" expects the latest tech at work 

In the past decade, electronic data capture (EDC) technology has proven its ability to fuel quantum leaps in the efficiency, quality and safety of research organizations’ work and, in turn, the quality of therapies and devices brought to patients. EDC software accelerates speed-to-market because researchers can identify and act on opportunities to pivot more quickly when data indicate. 

Finely detailed metrics can be set and acted upon immediately, so treatments showing promise can move forward, and those that don’t can be dropped earlier in the process. This capability – to act on data in real-time – not only helps decrease the costs and timelines of clinical trials, but it also increases quality and safety. 

And now, there's another good reason to adopt eClinical technology: Employee recruitment and retention – especially of younger workers.  

The Millennial generation and Post-Millennial generation (sometimes called the “iGeneration”) are digital natives whose expectations of how information technology can and should be used are significantly different from previous generations. They often have little patience for people who are wary of technology or strive to preserve manual paper-based methods. 

Millenials expect technology to connect them, in every way possible, to their peers, their work, and yes– their data. 

According to the Bureau of Labor Statistics, Millennials will account for 75 percent of the global workforce by 2025, so this is a group that can't be ignored.  If your eClinical technology isn't up-to-date – or is missing altogether – contact us now!  We can help make sure you're attracting (and keeping) the best and the brightest of the digitally-connected generation. 

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Topics: EDC, employee turnover, eclinical systems

Training Your Users on a New eClinical System (Without Tearing Your Hair Out)

Posted by Amy Young on Jan 14, 2016 3:31:12 PM

Clinical Data Management systems user training When you implement new Clinical Data Management Systems, how much of your time does end-user training eat up?  A day? A week? More? If you'd rather spend your time on other, more important tasks, you need to take a closer look at eCOS. 

In our system, you can track your user training right inside the program. No more developing extra documents and spreadsheets and manually tracking which employees completed their training (or passed a quiz). Your user training can be developed to fit your exact study needs and baked into the study design right from the start.

Another great benefit? Regulatory compliance. With this method, you can prove – with just a few mouse clicks – that users have completed training and demonstrated proficiency. 

Want to learn more about our training capabilities? Watch our previously recorded webinar, Study Start-Up and User Training with eCOS. You'll learn all about our training capabilities, plus get details on the custom start-up options that can help you and your clinical research study hit the ground running.  

Check it out here! 

(And it you want a more in-depth look at the total eCOS system, request a "Sandbox" account by hitting the link below.) 

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Topics: EDC, eclinical systems, study start up

Happy Holidays from eClinicalOS

Posted by Amy Young on Dec 23, 2015 10:50:41 AM

From our (corporate) family to yours – we wish you a happy, healthy, and restful holiday season! eclinicalos-clinical-data-management.jpg

You've worked hard all year doing the important work of clinical research. So as the holidays approach, we hope you have the chance to slow down and recharge. After all, we know you have big plans for 2016!  (So do we!) 

Looking back, 2015 was a pretty great year for our company. In May, we released Study Connect, a unique new mobile app that enables researchers like you to perform critical study-related tasks on the go. In August, we marked our third anniversary as eCOS by surpassing 500 active trials in our system. And, perhaps the biggest news of the year occurred in October, when our transaction with IBM was finalized, making us part of the IBM Watson Health family.

Great things are coming in 2016. Soon, we’ll be announcing some significant advances to our analytics capabilities. Smart reporting, data visualization, and data warehousing are just a few of the exciting features that we're working on.  Plus, throughout 2016 (and beyond), we will continue our integration with IBM. 

As the year winds down here at eClinicalOS HQ in North Carolina, it's feeling decidedly un-winterlike (70 degrees in December?). But we're filled the spirit of the season when we think about all of our wonderful customers and the great work we've accomplished together in 2015. So, from the bottom of our (sweaty) hearts, thank you!  We can't wait to see what 2016 brings!  

Topics: Merge eClinical, EDC, clinical trials, clinical data management

Have You Registered for Our Virtual User Group Yet?

Posted by Amy Young on Nov 24, 2015 2:57:10 PM

Be among the first to experience this new event! (Budget approval not required: it's free.) 

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Are you an eCOS user (or someone who's interested in using our clinical data management system for their next clinical research trial)? Do you have a computer and an internet connection? Great! That's all you need to attend our virtual user group webinar on December 10th. 

During the one-hour event, eCOS Sales Engineers will be on hand to address your most burning questions about the platform. This is a webinar that's all about YOU. When you register, you'll have theMerge eClinical Virtual User Group opportunity to submit discussion topics ahead of time so we can tailor the content to your needs. And, we'll leave time at the end for an open Q & A. 

Why are we doing this? Well, for starters, we want to make sure the eCOS user experience is the best it can be, and your feedback is an important part of that goal. Plus, we know not everyone has the time or the resources to attend a lengthy off-site user group meeting (although that sort of thing is definitely on our radar for the future). If all goes well, we're hoping to make the virtual user group a regular occurrence! 

Registering is easy: Just click the button below to be taken to the registration page. Then, look out for your confirmation email and pre-event survey. 

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Topics: Webinar, user experience, user group

eCOS Has the Solution to Holiday Week Boredom

Posted by Amy Young on Nov 19, 2015 10:30:00 AM

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Americans: Will your office look like this next week?

On November 26, all across the U.S., we celebrate Thanksgiving – a time to come together with family and friends, eat a whole lot of food, and reflect on the things we're grateful for. (At eClinicalOS, we're thankful for our wonderful customers, our smart colleagues, and the advanced technology that allows us to do our jobs.)

For most of us, Thanksgiving also means a 3-day work week (that is, if you aren't taking vacation to travel). What does that mean for those of us left behind? Usually, a pretty quiet office, fewer meetings, and, let's face it, less work to do. 

But wait - there IS something you can do to remain productive during this time: How about watching a free webinar? Coincidentally, we just added dozens of previously recorded one-hour presentations to our library, and they can be yours in an instant (did we mention for free)!

  • Find out about hidden shortcuts that can make you a faster user with Secrets of eCOS
  • Uncover a new way to perform source data verification (SDV) faster than ever before with our Monitoring Functionality demonstration
  • Learn more about Study Connect, the first mobile app of its kind for clinical researchers
  • Discover why more and more companies are leaving paper behind and embracing EDC

..And lots more!  See the entire webinar library here.  

Happy Thanksgiving! 

Topics: edc adoption, Webinar

Have Coffee With eCOS at PCT Europe, Booth 215

Posted by Amy Young on Nov 13, 2015 6:00:00 AM

The show starts Tuesday: Will you be there? 

The eClinicalOS European team heads to Hamburg, Germany next week for the annual PCT Conference (November 17 - 19). This year's theme is "The era of change: A panoramic vision of reform, challenge and innovation in clinical trials." 

The conference promises to provide great learning opportunities, networking, and more. While you're there, we hope you'll come by booth #215 and say hello (or "Guten Tag") to our team! Get recharged with some coffee from our in-booth Nespresso machine and learn more about eCOS, the world's best clinical data management platform.  If you need a visual reminder so you can find us, here's a preview of our space –  
 We'll also have some cool giveaways to share, so be sure to stop by! 
See you in Hamburg! 

Topics: EDC, pct, clinical data management

Modern Digital Automation: Good Thing or Bad Thing?

Posted by Amy Young on Nov 11, 2015 10:47:44 AM

Digital Automation in Clinical Data Management Software

Everything these days is becoming automated, thanks to advances in digital technology. But is more technology always good thing? Here's a brief look at the pros and cons of selected digital technologies – with a special focus on clinical research. 

Let's start with the most obvious (and most prevalent): Smartphones
PRO: 
Instant access to the internet, anytime, anywhere. Millions of apps can help you perform virtually any task in seconds. Your entire contact list, all in one place. Easy, instant communication via text, email, or phone call. 
CON: You don't remember anyone's phone number. You have thousands of virtual friends – but few actual conversations. Once, you nearly walked into a pole while responding to an important text. 

To point you in the right direction: GPS (aka Sat Nav) technology
PRO: Never get lost. No more printing out directions or (gasp) reading a map. All you need is an address and a device, and step-by-step, real-time directions are yours.
CON: Over-reliance on automated directions could leave you driving into a pond. Map-reading skills are going the way of the fax machine. 

For when the work day's over: Digital Video Recorders
PRO:
You never have to watch commercials again. Rushing home to watch your favorite show?  A thing of the past.
CON: You lose track of time while watching your recorded shows and stay up too late. You miss those few commercials that are actually worth watching. There are too. many. choices! 

So how about automation technologies specifically designed for clinical research?  Here's a look at some of the top advances of the past 10 years: 

Electronic Data Capture (Cloud-Based) 
PRO:
 Fewer mistakes. More convenient access to data. Accelerated trial timelines. Reduced cost. Easier compliance with regulatory requirements. Enhanced security and privacy of data. We could go on.  
CON: That's a tough one. Reduced revenue for paper companies, perhaps?

Electronic Endpoint Adjudication
PRO: 
33% reduction in timelines. Better quality control. Seamless EDC integration. Happier adjudicators. The confidence that comes with being in the company of top research organizations, like Harvard
CON: If you really, really enjoy preparing and shipping 3-inch binders, you might be disappointed. 

Electronic Randomization 
PRO:
Secure, reliable, automated randomization. Elimination of human bias. Ability to meet any stratification factors. Integration with inventory management and dispensing systems. 
CON: Clinical Operations professionals might have a lot of extra time on their hands! 

DICOM Image Management
PRO: Ability to collect, transport and access DICOM images right in your data capture platform. Easy, efficient workflows involving DICOM images. Effortless compliance with privacy guidelines. Fewer errors.
CON: No more stacks of CD cases to give your office that "college dorm room" ambiance. 


Unsurprisingly, we at eClinicalOS think automation in clinical trials is a very, very good thing. Want to read more on the subject? Download our latest article, "Digital Automation in Clinical Trials: The Promise and Potential." Here's to the transformative power of technology!

Download Article Now

Topics: EDC, clinical trials, Randomization, Endpoint Adjudication, automation, digital data management

The Meteoric Rise of (Electronic) Endpoint Adjudication

Posted by Amy Young on Nov 5, 2015 10:00:00 AM

The Rise of Endpont Adjudication

Endpoint Adjudication (EA) is having a bit of a moment. 

EA isn't a new concept, really. As long as there have been endpoints in clinical trials, there has been a need to resolve events related to safety and efficacy – and provide standardized endpoint outcomes for those all-important statistical analyses. 

What IS changing, however, is the way EA is performed. What used to be a very manual, time-consuming process is being transformed – along with everything else in our day and age – by the internet (and more specifically, the cloud). Electronic endpoint adjudication is gaining in popularity, quickly. 

Just last week, Applied Clinical Trials put out a call for input on a new survey designed to evaluate the impact of technology on Endpoint Adjudication processes. In their post, they call Endpoint Adjudication "an emerging field" that is "relatively new, but rapidly gaining traction." They also point out that "the adoption of endpoint adjudication as a business process and operational concept seems to be widely unknown and rarely spoken about in the industry." Interesting. We'll be watching this survey closely!

It goes without saying that we're big believers in the power of technology to gain efficiencies in clinical trials.  eCOS has a robust, well-established EA module that's unique in the industry - and we've been offering it for more than 10 years!  Our customers consistently tell us they love it. So much so that 90% of the world's top adjudication centers now use our solution

When you compare paper-based EA processes to digital, the benefits are clear. Check out how much electronic technology can cut timelines in this detailed chart: 

Endpoint Adjudication Paper vs. Technology

A 33% time reduction is nothing to sneeze at!  And, lest you think we made these numbers up, read the recent press release outlining Harvard Clinical Research Institute's experience with the eCOS EA module this year. 

Want to learn more about electronic Endpoint Adjudication? Head to our website, read this article, or watch a previously-recorded webinar demonstration* of our EA module. Or, feel free to contact us and a member of our team will be happy to walk you through it.

*Note: We'll be holding another live EA webinar on December 3rd, so stay tuned! 

Until then, you can watch our prerecorded Webinar about Endpoint Adjudication module in eClinicalOS: 

View Recording

Topics: Applied Clinical Trials, clinical trials, Endpoint Adjudication

Yes, You CAN Learn to Build Your Own Study Database (We'll Show You!)

Posted by Greg Pack on Nov 3, 2015 10:00:00 AM
eCOS Study Build Program Puts YOU in The Driver's Seat 

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"Clinical research is all about control – and those who choose careers in this industry want to retain as much control over a project as possible. eClinicalOS plays very nicely with this ideal given that it encourages those working with it (programming, conducting UAT, cleaning, etc.) to become self-sufficient."  
-Matt Dickason, Managing Director, Renaissance Associates* 
With trial costs at an all-time high, every minute of every day has a dollar amount tagged to it – and building out a study in a data management platform can be extremely time-consuming. So instead of paying other companies to build databases, what if  you could have someone trained in-house who can do it for you? That’s both productive and smart.

eClinicalOS' Mentor Build/Certified Designer program is unlike any in the industry. When you participate in our onsite build session (which usually takes about a week), you'll leave with the skills you need to build or modify your own study databases. (That's huge!) You'll also have the option to take a test and become an official Certified Study Designer. Imagine the possibilities: You can build and modify your own study databases, train others in your organization, or even contract employees out to build studies for other companies.
 
From Data Manager to Certified Designer – in One Week 
An eCOS Case Study 

When Clinical Data Manager Erin Piller participated in the eClinicalOS Mentor Build Program and became a Certified Study Designer, she gained a valuable skill – and her employer, Renaissance Associates, benefitted, too. Read on to find out how she was able to get certified, overcome her fears, and build value within her research organization – all in 4 days of training.

Q: Tell us about yourself!

Erin: I am the Data Manager at Renaissance Associates, a specialized CRO based in Orange County, California. I’ve touched every project from start to finish and have developed and grown the data management side of things since the beginning. In my day to day, I’ll do anything from protocol review to creating CRFs to programming databases. 

Q: How did you find out about eClinicalOS, and the mentor build program?

Erin: We discovered eClinicalOS during a recent RFP process for a client. After performing due diligence activities on multiple EDC vendors, we recommended eCOS to the client as our primary choice. The certified study designer training program was definitely a factor in our decision. The reason we recommended eCOS was in large part due to our ability to retain and perform all database programming activities on behalf of and with the full support of our study sponsor.

Q: What was your background and experience level going into the training?

Erin: Prior to working at Renaissance, my previous experience was in the advertising industry with a focus on research and media planning. In my work at Renaissance, I programmed many databases, but had no experience with eCOS.  

Q: How did you prepare for your certified designer training?

Erin: I sat through a couple of webinars, then got my hands on a Sandbox account. I played with the Sandbox feature as much as I could, and started poring through the manual. I was looking at just about anything I could get my hands on, preparing myself for my trip to Raleigh.

Q: What was the training experience like for you?

Erin: Last year, I had a weeklong training effort with [eCOS Trainer] Joseph Maxey. I was confident that I could develop a useable database, even though we had a project with some tight deadlines. It was a very intense week of training. I’d say by the third or fourth day it was starting to make a lot of sense. 

I loved attending the training. Everybody at eClinicalOS was super nice. By the end of the week, I felt like I was part of the company. It was a fun, relaxed and valuable experience.

At the end of the week I was somewhat nervous to leave Raleigh and come back and build a study on my own. As with all studies, there was a mandate that we adhere to strict budget parameters. I wanted to learn not only the right way to program, but the right way to program to ensure the efficient and cost-effective use of the eCOS system by all stakeholders. 

Q: How are things going now?

Erin: There was an unanticipated delay in study start, but upon leaving the training, I was confident that I could have made it work if we were told to “go live” when originally scheduled. So kudos to you guys for getting me up to speed that quickly! I think that was amazing.

So far everything’s working great. The client is really happy with how the database was put together, and that we were able to build in some features that even they didn’t know they would want.

Being able to do that on our first study using eClinicalOS - no templates or anything to work from - just amazed all of us here at Renaissance (as well as the client). So going forward, I have a knowledge base of eCOS to use for future studies. Of course I’ve learned a lot along the way, but I also have templates that I can already build from, which are huge timesavers. So I’m really looking forward to our next study in eCOS, because I want to see how fast I can get.

Stay tuned for part 2 of this story, in which we interview Trainer Joseph Maxey to get his side of the experience!  

*Renaissance Associates is a specialized Contract Research Organization (CRO) located in Newport Beach, California. Renaissance Associates focuses on late phase biopharmaceutical and early/late phase medical device/diagnostic study design and execution.

 If you would like to contact Renaissance Associates for further information, please see their details below:

Renaissance Associates
1600 Dove Street, Suite 330
Newport Beach, CA 92660

Email: matt.dickason@renaissanceassoc.com 

949.752.5700

Renaissanceassoc.com


Free webinar: How to Cut Your Study Build Time in Half

Interested in some tips and tricks on how to cut your study build time by as much as 50%? Watch our previously recorded free webinar

Topics: CRO, clinical data management

Decoding eClinical Abbreviations

Posted by Amy Young on Oct 29, 2015 10:00:00 AM

startup-photosJargon. Love it or hate it, every industry has it. If you're new to the eClinical world - or even if you've been around for years - certain acronyms and abbreviations might leave you confused. eClinicalOS comes to the rescue with this handy glossary. Bookmark it and share with your colleagues! 

API: Application Programming Interface 
eClinicalS features an "open API," which means you can import data from a variety of sources without having to perform data entry. One of the most popular features in our system is our open API with Almac (for easy inventory and shipping management). 

ARO: Academic Research Organization
One of the world's most famous AROs is Harvard (a great organization that happens to be a fan of eClinicalOS!) 

CDM: Clinical Data Management
CDM is pretty much what we're all about at eClinicalOS. We're very proud of our CDMP (Clinical Data Management Platform).

CRF: Case Report Form
A CRF is the tool used to collect data on a patient in a clinical trial. Before EDC, most researchers used paper CRFs. Today, EDC has been found to be much more efficient - and less prone to errors. Some sites use a combination of paper CRFs and EDC. You'll also hear the abbreviation "eCRF" used to refer to electronic CRFs. 

CRO: Clinical Research Organization
We're proud to say that 8 of the world's top 10 CROs use eClinicalOS.

CTMS: Clinical Trial Management System
Did you know that we have the very first (and still the best) CTMS Solution

DICOM: Digital Imaging and Communications in Medicine
DICOM is a standard for handling, storing, printing, and transmitting information in medical imaging. The eCOS DICOM module can help you manage images with ease. 

EA/EAM: Endpoint Adjudication/Endpoint Adjudication Module
We happen to have a pretty great EA solution. Learn more about it here and here

eCOS: A shorter way to say eClinicalOS.
We've been "eCOS" for over 3 years now. Check out this year's biggest accomplishments

EDC: Electronic Data Capture 
Up to 77% of clinical researchers say they prefer EDC to paper. Read the industry report for more EDC trends.

ePRO: Electronic Patient Reported Outcomes
Essentially a digital diary, ePRO lets you collect data directly from patients when studies require them to record compliance with meds, pain levels or other details outside of their clinic visits. Read more about eCOS' ePRO.

IWR: Interactive Web Response
Features such as Randomization and Inventory/Dispense are considered IWR technologies. The term "IxR," which basically means "Interactive [something] Response" is also common in the industry. (So is "IVR" - Interactive Voice Response.)

SDV: Source Data Verification
Monitoring the accuracy of data entry in a clnical trial can be very expensive and time-consuming. The SDV feature within eCOS makes it much faster! 

UAT: User Acceptance Testing
UAT is a phase of software development in which the software is tested in the "real world" by the intended audience or a representative. Over the years, we've developed a robust, efficient UAT process

Of course, this isn't an exhaustive list (especially if you include the broader clinical research world, with its CRAs and CRCs,etc), but we hope this guide helps you de-mystify those sometimes cryptic eClinical abbreviations. Did we miss any big ones? Let us know

Webinars, webinars, webinars: We've got webinars!

Want to learn more about all things eClinical? We offer regular (free!) webinars on a variety of industry topics. Visit our webinar page to learn more. 

Topics: Merge eClinical, EDC, clinical data management, abbreviations, eclinical systems

8 Signs You're With the Wrong Clinical Data Software Provider

Posted by Amy Young on Oct 27, 2015 10:00:00 AM

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Some time ago, you decided to switch from paper to an eClinical system. But now that you've been with that provider for a while, does your relationship feel a bit...strained?  

Perhaps you're underwhelmed by their (lack of) customer service. 

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Or maybe the vendor tried to lock you in to a long-term commitment that only seems good for them. 

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Getting charged for extras you weren't prepared for? That can really add up. 

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And slow study build times can cause a domino effect of problems.  

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Want to know more about these signs (plus 4 more)? Download our eGuide today! It details all the signs and symptoms of a less-than-ideal clinical data software vendor relationship. Plus, the guide also walks you through the process of vetting and selecting a vendor that's truly right for your business. 

Get the eGuide now! 

 

Topics: edc adoption, Switching EDC, clinical data management, clinical systems

New Release: eClinicalOS v2015.10.0

Posted by Sean Farres on Oct 20, 2015 9:00:00 AM

We are pleased to announce the release of Merge eClinicalOS v2015.10.0 on Friday, November 6, 2015.  

This release includes new customizable subject PDFs as well as enhancements to existing tools. 
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Here are a few highlights of the upcoming release:

New Customizable Subject PDFs 

We are releasing a new tool for Subject PDF generation. When you turn this feature on for your study, you will be able to define templates for the Subject PDF in the Closeout > Study Documents/Exports. This includes reordering pages, managing content, and setting naming conventions. You can save the settings to a template for re-use. You will also be able to generate by country, site, or subject.

Enhancement to the Endpoint Workflow

While the Endpoint Adjudication module allows auto-assignment of adjudicators, some studies require manual assignment in their workflow. Currently, this requires a user to individually access and update each event that is ready. With the release of eClinicalOS v2015.10.0, a new tool will allow users to view the 'available' events, select from this list, and batch assign an adjudicator to the selections.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: support@eclinicalos.com 
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, EDC, System Update, Update, EAM, Endpoint Adjudication

IBM Closes Deal to Acquire Merge Healthcare

Posted by Amy Young on Oct 13, 2015 1:58:00 PM
Merge to become part of IBM’s new Watson Health business unit

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Armonk, NY and CHICAGO – 13 Oct, 2015: IBM (NYSE: IBM) today announced that it has completed the acquisition of Merge Healthcare Incorporated, a leading provider of medical image handling and processing, interoperability and clinical systems. Under terms of the $1 billion transaction, Merge shareholders will receive $7.13 per share in cash.

Merge’s technology platforms are used at more than 7,500 U.S. healthcare sites, as well as many of the world’s leading clinical research institutes and pharmaceutical firms to manage a growing body of medical images. It is anticipated that these organizations will look to use the Watson Health Cloud to surface new insights from a consolidated, patient-centric view of current and historical images, electronic health records, consumer contributed data from wearable devices and other related medical data, in a HIPAA-enabled cloud environment. These insights can help clinicians to efficiently identify options for the diagnosis, treatment and monitoring of a broad array of health conditions such as cancer, stroke and heart disease.

Merge will become part of IBM’s new Watson Health business unit, bolstering IBM clients’ ability to analyze and cross-reference medical images against 315 billion data points already in the Watson Health Cloud, including lab results, electronic health records, genomic tests, clinical studies and other health-related data sources. Merge’s clients could compare new medical images with a patient’s medical history as well as populations of similar patients to detect changes and anomalies. Insights generated by Watson could then help healthcare providers and researchers to pursue more personalized approaches to diagnosis, treatment and monitoring of patients. 

About IBM Watson Health 

Watson is the first commercially available cognitive computing capability representing a new era in computing. The system, delivered through the cloud, analyzes high volumes of data, and complex questions posed in natural language, and proposes evidence-based options. Watson continuously learns, gaining in value and knowledge over time, from previous interactions. In April 2015, the company launched IBM Watson Health and the Watson Health Cloud platform. The new unit will help improve the ability of doctors, researchers and insurers to innovate by surfacing new insights from the massive amount of personal health data being created daily. The Watson Health Cloud allows this information to be de-identified, shared and combined with a dynamic and constantly growing aggregated view of clinical, research and social health data. 

About IBM 

For more information on IBM Watson, visit: ibm.com/watson. For more information on IBM Watson Health, visit: ibm.com/watsonhealth 

Check out the IBM Watson press kit at: http://www-03.ibm.com/press/us/en/presskit/27297.wss

Join the conversation at #ibmwatson and #watsonhealth. Follow Watson on Facebook and see Watson on YouTube and Flickr. 

Learn more about this story at: http://asmarterplanet.com/blog/2015/08/seeing-believing-bringing-cognitive-image-analytics-healthcare.html and https://www-03.ibm.com/press/us/en/pressrelease/47435.wss   

Media Contact 

Christine Douglass
IBM Media Relations 
415-535-4479 (mobile) 
cgdouglass@us.ibm.com 

Topics: Merge eClinical, clinical trials, Merge Healthcare, acquisition, clinical systems, IBM

News: eCOS Endpoint Adjudication Helps Harvard Streamline Operations

Posted by Amy Young on Oct 12, 2015 11:40:00 AM

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Harvard Clinical Research Institute (HCRI) has long been a leader in the academic research space, and their work has produced groundbreaking research results - particularly in Cardiology. 

HCRI is also a leader in the practice of endpoint adjudication. Since 1999, HCRI's Clinical Events Committee (CEC) has delivered high quality and consistent adjudication of reported endpoints to their many sponsors.  Examples include the conception and leadership of numerous Academic Research Consortia (ARC, VARC, and BARC), adjudication and analysis for FDA special panel meetings, and the support of over 100 successful PMA and NDA submissions. 

But as successful as their CEC was, Harvard knew they could improve - especially when it came to adjudication timelines.  So in 2015, they implemented the eClinicalOS Endpoint Adjudication Module (EAM).

"Before eCOS, we had very highly regarded endpoint adjudication processes, but we were still performing many tasks in a manual fashion," said Michelle Escarfullery, business manager for Clinical Review and Safety. "With the eCOS EAM, we've cut our timeline by an average of 30 percent."

He also noted that the EAM’s flexibility was a primary factor in HCRI’s selection of eCOS. “Number one, we needed an option that would let us tailor aspects of the workflow to our needs, and eCOS fits that perfectly,” Mr. Escarfullery said. “For example, we can now easily modify adjudication forms to match the needs of specific studies. The module’s ability to let us customize eCRF pages means that our team can collect source documents and translate them into multiple languages in one central location.”

Read more about it in a news release that posted today. 

Harvard is in good company. Since 2004, our customers have benefited from the power of the eCOS EAM module.  In fact, earlier this year, Medical Device CRO RCRI even blogged about their process.  

Ready to put the eCOS EAM to work for your organization? Contact us today to get started! 

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Topics: FDA, Endpoint Adjudication, academic research, harvard clinical research institute

Why Clinical Researchers Should Care About Big Data

Posted by Amy Young on Oct 7, 2015 4:38:30 PM

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If there was ever any doubt that "Big Data" has made its way into the world of clinical research, check this out: there's a conference happening this week dedicated entirely to the subject.  

Big Data in Clinical Development  promises to be "the world’s most disruptive and innovative forum to tackle the complexities of R&D data and its application in clinical care." 

According to the organizer's website, "Big Data will be the critical source of competitive advantage for years to come." And researchers should use it to "Find the next source of innovation by extracting meaningful data from your early discovery resources." 

We tend to agree. In an article out this week in the Journal for Clinical Studies, we talk about the confluence of Big Data, Personalized Medicine, and EDC - and the potential it holds for the industry. The article provides an overview of how clinical researchers can leverage advanced information technology (like cloud-based EDC and IWR systems) to strengthen their ability to meet the demands of increasingly complex studies and larger data sets – all while remaining compliant within an ever-changing regulatory landscape. 

Download the article and read it now by heading here! 

Topics: EDC, Pharma, Big Data, personalized medicine

Site Solutions Summit Starts Thursday: Don't Miss Out! 

Posted by Amy Young on Oct 6, 2015 10:00:00 AM
Global Site Solutions Summit 2015: Amelia Island, Florida, October 8 - 11 

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Starting this Thursday (October 8th), members of the Merge eClinicalOS team will be in Amelia Island, Florida attending the Global Site Solutions Summit, hosted by the the Society for Clinical Research Sites (SCRS). This annual one-of-a-kind event provides networking, learning opportunities, and actionable strategies to help your company grow and thrive.

With no hurricanes in sight (phew), we're packed and ready to go!  

Will you be there? If so, we'd love to meet you!  Check your attendee bag for our postcard, fill it out, and come by booth #35/36. You can pick up some free goodies - AND get a chance to win a Fitbit! Plus, you can learn all about CTMS for Investigators, the first - and still the best - CTMS system for efficient site management. 

If you're short on time and want to schedule a meeting in advance, you can do that too. Just click below:

Let's meet at SSS! 

See you in Florida! 

Topics: Conferences

Mobile Technology and the Future of ePRO

Posted by Amy Young on Sep 29, 2015 10:00:00 AM
Use of Electronic Patient-Reported Outcomes (ePRO) in clinical trials is growing, thanks to cutting-edge mobile tech. But can it really give us accurate information? 

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Electronic patient-reported outcomes (ePRO) technology was once easy for some to dismiss as an attention-grabbing but unwarranted clinical research cost. Today, it has become a highly effective means of attracting and engaging trial participants. ePRO is especially useful for gathering data that can prove critical in a drug’s progress by helping prove value of a candidate with investors and regulators. 

So what is driving ePRO advancement and adoption? It’s a mixture of mobile communication, software development and sci-fi inspired tech. 

Building candidate pools

Rapid advances in mobile communication have pushed down the cost of smartphones and increased the utility of using them to attract trial participants. 

While Apple’s new smartwatch grabbed headlines with its pre-order sellout, in clinical circles the company’s open source ResearchKit software was the real news. Two recent developments strongly suggest that the software and iPhones will be a boon to trial recruitment and monitoring. Consider:

  • A new Parkinson’s app helped Sage Bionetworks sign up 7,406 patients for a Parkinson’s Disease trial in six hours. Previously, the highest study recruitment level was 1,700 subjects. 
  • Stanford University researchers found that 11,000 people had signed up for a cardiovascular study in less than 24 hours. Normally, it would have taken a year to reach that level at more than 50 research sites nationwide.

But as Bloomberg reported, even though Apple created a pool of hundreds of millions of iPhone owners worldwide with ResearchKit, Apple’s more affluent and educated customers could skew study findings compared to Android users, of which there are more worldwide. 

Moreover, experts counter that additional development in accurate information gathering – from misplaced finger falls by prospective trial candidates on their mobile keyboards to getting accurate responses to the kinds of questions normally asked face-to-face – will need monitoring and development.

Remote monitoring

The monitoring and compliance process is where ePRO’s stickiness was questioned. Clunky and expensive custom ePRO devices that trial subjects were unlikely to carry at all times hindered use and development. This is where leading-edge technology is allowing sponsors to gather data in ways previously only imagined.

Take the Scanadu Scout for example. Hold this non-invasive device to your forehead, and it measures heart rate, temperature, blood pressure, oxygen levels and a complete ECG reading. It then transmits that data to a mobile device via Bluetooth technology. And as cool as that technology is, these developments are almost jaw dropping:

  • Under-skin Sensors –Texas A&M University researches have developed a tattoo that monitors glucose levels for diabetic patients. Once implanted, the tattoos can be read externally by a device that provides immediate data that can be collected, analyzed and acted upon wirelessly. 
  • Smart Contact Lens – Another glucose-monitoring device, this contact lens from Novartis is equipped with an antenna and a chip.
  • Skin-printed Sensors – A materials scientist at the University of Illinois at Urbana-Champaign has developed “epidermal electronics.” Comprising ultrathin electrodes, sensors and wireless power as well as communication systems, these devices attach to the skin and record and transmit electrophysiological measurements. 
  • Digital Pills – An ingestible pill with a tiny silicon chip containing trace amounts of magnesium and copper generates, when swallowed, a low-level voltage signal in response to digestive juices. The sensor sends a signal to the surface of a person’s skin where a patch then relays the information to a mobile phone belonging to a healthcare provider. The pills could provide alternatives to doctor visits, blood tests, MRIs and CAT scans.
eCompliance

Where the use of smartphones and tablets will especially shine will be with data recording compliance. Because e-diaries reduce trial subjects’ burden of documenting product use, side effects, and other data, they significantly improve compliance and retention. What’s more, there’s tremendous flexibility within and among devices for communication.

Data entry can be conducted once daily, and reminders for missed entries can be automatically delivered via email or text message. Best of all, subjects can respond at their convenience, eliminating the need for phone calls and follow-up scheduled at the researcher’s availability.

From the relatively simple monitoring of trial participants to almost futuristic advancements, with so many current and future uses, the prospects for ePRO to help streamline and improve the quality of trials are bright, indeed.

Interested in an ePRO solution? We happen to have a great one (and it works on virtually any device). Read all about it!

 

Topics: ePro, mHealth

New Release: eClinicalOS v2015.9.0

Posted by Sean Farres on Sep 22, 2015 11:00:00 AM

We are pleased to announce the release of Merge eClinicalOS v2015.9.0 on Friday, October 2, 2015.  

eClinicalOS v2015.9.0 includes Endpoint Adjudication updates as well as enhancements to existing tools. 
eam_01

Here are a few highlights of the upcoming release:

Endpoint Adjudication Updates

Currently, Endpoint Adjudication users can access an extensive history that can include clinical and adjudication data, but is limited to one event at a time. Based on user feedback, eClinicalOS v2015.9.0 adds a study-level report. It is available on the Study Documents/Exports section of the designer and outputs in CSV format.

Document Format Updates

Recently, the Subject PDF generation in eClinicalOS was updated to meet FDA submission guidelines. With the release of v2015.9.0, the same formatting requirements are being applied to the Blank CRF and Unique CRF reports. Also, the Study Design Documentation has also been updated to better conform to the requirements.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: support@eclinicalos.com 
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, EDC, System Update, Update, EAM, Endpoint Adjudication

Do You Like Our New Face?

Posted by Amy Young on Sep 18, 2015 10:52:17 AM

Have you been to the homepage of eClinicalOS lately?  If not, go check it out! We got a new look this week and, like any patient with a successful facelift, we're excited to show it off. 

Our new design will help make the site more user friendly and look better on mobile devices. We've also added our brand-new company video!  When you go to the homepage, you can check it out by clicking on the blue play arrow in the middle there.  ↓

Fun fact: The two actors you see on our front page are actually eClinicalOS employees! We're lucky to work with such good-looking forehead models.

Also new: A sticky navigation bar:

The semi-transparent sticky navigation bar that you see on top of the new homepage is now on ALL site pages. Plus, a Google search field has been incorporated for easier site navigation (it automatically collapses when scrolling down the page). This feature is especially valuable when visiting the site on a mobile device or tablet:

We hope the new look and design helps you navigate our site with greater ease and efficiency (especially on mobile devices). Oh, and we'll share a little secret - this is only the beginning! We'll be rolling out additional updates and enhancements to the site in the coming months. After all, at eClinicalOS, we're all about the user experience - in our product AND on our site.  We hope to see your face in our place a lot more often! 



Topics: clinical research, Video, Update, user experience

4 Things Not to Miss at the Global Site Solutions Summit

Posted by Greg Pack on Sep 17, 2015 10:13:21 AM

It's coming soon! From October 8th through the 11th, members of the Merge eClinicalOS team will be in Amelia Island, Florida attending the Global Site Solutions Summit, hosted by the the Society for Clinical Research Sites (SCRS). This annual one-of-a-kind event provides networking, learning opportunities, and actionable strategies to help your company grow and thrive.


Merge eClinical will be a featured “2015 Impact Partner” at this year’s SSS conference, and members of our staff will be offering study design tips, system tricks and demos of our award winning clinical research study management platform, CTMS for Investigators. Stop by booth #35/36, pick up some free goodies, and say “hello!”

Here are 4 things you won't want to miss at this years SSS:

  1. SCRS/CISCRP Medical Heroes 5k Run/Walk, Sunday Oct 11th at 7am. Get up early and get your exercise on while supporting a great cause! 
  2. The SCRS Eagle Award: This award recognizes the sponsor and CRO organizations who are dedicated to creating positive relationships with sites. The 2015 Sponsor finalists are: Amgen, Astellas, AstraZeneca, Eli Lilly & Company, Ferring Pharmaceuticals Inc., Gilead, GlaxoSmithKline, Janssen Pharmaceuticals, Merck & Co., Nektar, Novavax, Novo Nordisk, and Pfizer. The 2015 CRO finalists are: INC Research, iVentiv Health, Medpace, PAREXEL International, PRA Health Sciences, Quintiles, and Target Health Inc. Who will win? 
  3. Networking, Networking, Networking! Tap into SCRS’ network of sponsors and CROs seeking purposeful site partnerships. Here are a list of companies attending the Site Solutions Summit
  4. Site Partnership Symposiums: The symposium is a platform for leading sponsor/CRO organizations to engage in high-level dialogue and directly interact with site decision-makers. Symposiums focus on promoting knowledge and mobilizing insight into study pipeline opportunities. Lilly is hosting the first symposium on Oct 8 from 2-4pm, and Quintiles will host their symposium on the same day from 530-8pm. Don’t miss this opportunity! 

Not yet registered for the Summit? Use this link to register or modify your registration. If you need assistance, please contact Ross Flanigan at ross.flanigan@myscrs.org or 410-696-5080 x121

Want to set up a meeting with us in advance? Do that here:

Let's meet at SSS! 

We can't wait to see you in Florida!  

Topics: Conferences

eCOS' Chad Papineau to Speak at OCT New England

Posted by Greg Pack on Sep 4, 2015 10:00:00 AM

 

Chad_headshotOn September 16 & 17, senior-level clinical research professionals from all over the globe will gather in Boston for the 7th Outsourcing In Clinical Trials New England conference. The event offers attendees the opportunity to hear case study examples, attend intimate roundtable discussions, and much more.  

"This year OCT will be focusing on all aspects of outsourcing, including patient centricity, working collaboratively with vendors, financing, and meeting deadlines - just to name a few of the challenging topics. The program for 2015 brings new and exciting interactive presentation formats, increased networking opportunities, and 50+ executive level speakers from within the industry." 

- Excerpt from OCT New England Website  

Our own Senior Director of Business Development, Chad Papineau, will be speaking on the topic "Supporting Continuous Quality Improvement Through eClinical Technology" on Thursday September 17th at 10 a.m. His talk will cover: 

  • Utilizing eClinical systems (particularly cloud-based systems) to help studies run more smoothly
  • How to evaluate cloud-based software to ensure you're getting the features you need 
  • Why implementing cloud-based systems for more complex clinical trials can significantly increase data monitoring and reporting efficiency and support your organization's CQI efforts

It's truly a don't-miss event! 

Our team will also have a presence in the exhibit hall, so come on over and say hello! Stop by booth #45 for a demo of eClinicalOS (eCOS), our award-wining cloud-based clinical data management platform, and let us know how we can help you run your studies more efficiently (and cost-effectively) than ever before. If you'd like to arrange a meeting in advance, you can do that here.  

See you in Boston! 

 

 

Topics: EDC, personalized medicine

The Promise of Mobile for Clinical Trials

Posted by Amy Young on Sep 2, 2015 9:30:00 AM
Mobile and wearable technologies are "cool," but are they really making a difference in clinical trials? Zaher El-Assi, president of eClinicalOS, talks to Clinical Leader about the current and future state of mHealth.

hands-coffee-smartphone-technology-large

In the first of a two-part interview with Clinical Leader, our company's president talked to Chief Editor Ed Miseta about overseas markets and the opportunities they offer for companies conducting clinical trials. 

In part 2 of this feature, El-Assi discusses the status of mobile technologies in clinical studies and the potential they hold for transforming trials via their application to big data.

Here's a snapshot on his take on tech.

The state of mobile today... 

  • Wearable devices collect some data, but it's limited to items like calories, steps and heartbeats.
  • A number of mobile/tech devices are under development but not quite ready for prime time yet. 
  • Mobile apps, like Study Connect from eClinicalOS, are available - now -  to help researchers track high-level data on their studies (like finding out immediately if a patient experiences an adverse event).

What lies ahead? 

  • Devices like the Scanadu Scout will help us collect more data points on patients. 
  • Big data is only going to get bigger (thanks to these devices), so we will need to change how we analyze it. Quick reaction times will be crucial.  
  • Eventually, big data will help us develop more adaptive trials and more precise medicine.  

Read the article now!

clnicalleader

 

Topics: EDC, Pharma, clinical research, mHealth, In the News, wearables

"Insane Growth" and "Unique Potential" Seen in Emerging Markets

Posted by Amy Young on Aug 27, 2015 9:00:00 AM

clnicalleader

Our president, Zaher El-Assi, spends a lot of time traveling around the globe to locate growth markets for clinical research. Recently, he had the opportunity to explore two very different, but equally enticing regions: China and South Africa.  

In the first of a two-part interview with Clinical Leader, El-Assi sat down with Chief Editor Ed Miseta to talk about these overseas markets and the potential they hold for companies conducting clinical trials. 

Here's a snapshot of the clinical research opportunities identified in these corners of the world. 

China

  • Offers a lower cost to perform trials
  • Has a large patient population
  • Is one of the fastest-growing clinical trial markets globally: went from 23rd to 12th in the number of sites in just one year

(Read more of our thoughts on clinical research in China here and here.) 

South Africa 

  • Displays a growing need - and desire - for technology to perform clinical research
  • Has a very active professional organization offering attractive industry networking opportunities (SACRA: South African Clinical Research Association)
  • Maintains a diverse patient population
  • Offers unique business opportunities with upcoming health screening initiatives

Read the article now!

And stay tuned for part 2 of this feature, in which El-Assi discusses mobile technologies, the promise they hold for trials, and where they stand today.

 

Topics: EDC, Pharma, Outsourcing in Clinical Trials, clinical research, In the News

Recap: "3 Epic Years of eCOS" Celebration!

Posted by Amy Young on Aug 25, 2015 2:00:00 PM

Last week, the eClinicalOS tribe in our North Carolina headquarters (nearly 100 of us!) gathered at a local Mexican restaurant to celebrate "3 Epic Years of eCOS!"

3YearsPPT

In between bites of fajitas and tres leches cake (hey, that's one leche for every year) we reflected on just how far we've come since our company became eClinicalOS in 2012. (Come to think of it, we've come a long way in just ONE year - check out our year-in-review here!)

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So what's "epic" about eCOS? Plenty! We've got a great product line-up that we're continually improving, thanks to feedback from our awesome customers. Plus, we get to work with the smartest people in the business - all of whom care deeply about our company's - and our customers' - success. This winning formula is what allowed us to surpass 500 live trials this year and experience double-digit growth! 

Zspeakingatparty

"What you all have accomplished in just three years is nothing short of amazing," said Zaher El-Assi, president of eClinicalOS. "I'm so proud of everything we've done together – and with the exciting developments we've witnessed recently, there's no limit to how far we can go!" 

During the party, we were also treated to a screening of our yet-to-be released company video (coming soon - watch this space!). The video offers a high level overview of our company and our products – and features cameo appearances by many eCOS employees (word on the street is they're applying for their SAG cards as we speak). 

mktgvideo

Full and happy, we all left the party grateful for our inspring coworkers and the forward-thinking organization behind us. And thank you to our phenomenal clients all around the world who've made our success possible!

The future is bright, and we're ready for the ride - come join us!

peeps1peeps2peeeps4mktteampeeps3

Topics: Merge eClinical, anniversary, Celebration

New Release: eClinicalOS v2015.7.0

Posted by Sean Farres on Aug 20, 2015 2:00:00 PM

We are pleased to announce the release of Merge eClinicalOS v2015.7.0 on Friday, August 28, 2015.  

eClinicalOS v2015.7.0 includes information on the Advanced Expression Editor as well as some other enhancements to existing tools.

V2-Exports_ByRevision

Here are a few highlights in the upcoming release:

Advanced Expression Editor

Our expression editor - used for system queries, auto calc fields, and visit schedule rules - has undergone an upgrade. Based on user feedback, we have revised the overall look and feel of the tool - better drag and drop, more interactive attributes, and new menu options. One of these contains common expressions that you can drag into your workspace and fill in the blanks with study details. 

Data Tracker Charts and Metrics

One of our more popular Study Reports has also undergone an upgrade. You can now designate fields on the report for charts and metrics - a subreport where you can view data in pie or bar charts, scattergrams, and additional tables. The data is based on your main report filters but can be manipulated using the chart legends. You can also jump directly to the subject or data from the charts and tables.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, Reports, advanced expression editor, EDC, reporting, Data tracker, expression editor, System Update, Update

eClinicalOS President Talks to Pharmaceutical Outsourcing

Posted by Amy Young on Aug 18, 2015 9:24:00 AM

Pharmaceutical-Outsourcing

At the 2015 DIA Conference in Washington, D.C., Mike Auerbach of Pharmaceutical Outsourcing sat down to talk with our President, Zaher El-Assi, about the benefits of eClinicalOS. Watch the video below to learn more about our fully customizable EDC and Clinical Trials Management system that can save users both time and money. 

Topics: EDC, DIA, In the News, Video, pharmaceutical outsourcing

PharmaVOICE: DIA 2015 Interview with eClinicalOS President

Posted by Amy Young on Aug 17, 2015 9:29:00 AM

pharmavoice

At the DIA Conference in Washington, D.C., Merge eClinical President Zaher El-Assi discussed EDC consolidation, the adoption of adaptive trial designs, ways to minimize trial risk, and industry innovation with Taren Grom, Editor of PharmaVOICE Magazine. Watch the video now! 

Topics: EDC, DIA, pharmavoice, In the News, Video

Big News: eClinicalOS + IBM Watson!

Posted by Amy Young on Aug 14, 2015 2:32:11 PM

eClinicalOS Welcomes Watson!

The hallways at eClinicalOS headquarters are positively buzzing this week! Why the fuss? Well, we just got some VERY exciting news about our future. (We think you’ll find it to be great news, too!)  

As you may have heard, Merge Healthcare, the parent company of eClinicalOS, announced last week that we have entered into a definitive agreement under which IBM plans to acquire Merge Healthcare. After closing, Merge Healthcare (and the Merge eClinical division) will become part of the IBM Watson Health unit. 

watson_banner_image

Joining together our strengths as a leader in clinical trial management software with IBM’s powerful Watson Health Cloud cognitive and analytic capabilities will enable us to exponentially expand the reach and effectiveness of our solutions. 

We foresee a future in which healthcare and clinical research organizations can use the Watson Health Cloud to glean new and exciting insights from a multitude of data sources. Additionally, we hope to gain huge benefits from the ample resources IBM can offer to support the continued growth and development of our business.  

Reaction from Merge Leadership 

Justin Dearborn, chief executive officer of Merge, is thrilled by this development. “Merge is widely recognized for delivering market leading imaging workflow and electronic data capture solutions,” he said. “Today’s announcement is an exciting step forward for our employees and clients. Becoming a part of IBM will allow us to expand our global scale and deliver added value and insight to our clients through Watson’s advanced analytic and cognitive computing capabilities.”

Zaher El-Assi, president of the eClinical division, also had positive things to say about the IBM-Merge agreement. "The application of advanced IT to the drug and device development process continues to be the most significant trend in clinical research today," he said. "We believe the ability to tap IBM's global data management expertise and the capabilities of Watson, the world's most powerful supercomputer, will help eClinicalOS clients – and our team – advance clinical research and improve the human condition in truly historic ways.”

No changes in day-to-day business expected

Until the close of this acquisition, we want to assure you that nothing is changing for you, our customers and users. After close of this transaction, Merge products, including eClinicalOS and CTMS for Investigators, will only become better – and you will benefit from continued innovation to support your clinical research needs. 

In short, this is our promise: You can continue to expect the same level of service that you have come to rely on from eClinicalOS. 

Announcement only the first step

While we are very excited about the news, this is just the first step in the process. This transaction is subject to regulatory review, Merge shareholder approval and satisfaction of customary closing conditions and is expected to close later this year. Until the transaction closes, Merge will remain an independent company, and it is business as usual. We remain focused, as we always have, on execution and results, and will continue to deliver the innovation and support that you have come to expect from us.

We’ll stay in touch as future developments take place. If you have any questions about this announcement, please don’t hesitate to reach out.

As always, thank you for your continued business and ongoing support. We're proud to say that we have the very best customers and users in the industry, and that is one thing that will never change. 

You can read more abou the Merge Healthcare and IBM acquisition here.

Topics: Merge eClinical, eclinical systems, IBM

The SCDM 21st Annual Conference is Fast Approaching!

Posted by Greg Pack on Aug 13, 2015 2:38:52 PM

LOGO_SCDM_15_Washington.ashx-2The Society for Clinical Data Management (SCDM) (@SCDM_DataDriven)  is a non-profit, international organization of 2,400+ members dedicated to promoting quality and excellence in data management through professional development, education and certification.

On Sept 20th through 23rd, the SCDM annual conference in Washington D.C. will bring together clinical data managers and tech companies from around the globe to discuss current trends and innovations in research. It's the largest Clinical Data Management event in the industry, and members of the eClincalOS team (@goecos) are excited to be attending and exhibiting at this years show!

#Smartresearch

Among the many topics near and dear to us to be covered this year are best practices for managing clinical databases. Plus, the SCDM conference will offer several learning sessions and roundtable discussions to discuss the leveraging of electronic data management for operational efficiencies.

Come See us!

If you're going to the conference, please stop by Booth #110 and say “Hello!” There will be several members of the eClinical staff on hand to discuss new innovations in clinical data management and provide quick demos of our award winning electronic clinical data management platform. We're also planning some great giveaways that you won't want to miss!  

If you'd like to schedule a meeting with us in advance, it's simple! Just click the button below:

Let's Meet at SCDM!

For more information on SCDM’s 21st Annual Meeting, Click here

SDCM Resources page – webinars, online courses, certifications

Topics: EDC, scdm

Chinese FDA Tightens Regulatory Controls on Trial Data

Posted by Amy Young on Aug 5, 2015 3:15:00 PM
Compliance with self-inspection mandate required by August 25th

shanghai

The China Food and Drug Administration (CFDA) is making a push to ensure the accuracy of clinical trial data and drug quality (as well as proper record-keeping) for its 1,622 currently pending drug registration applications. This includes both imported and local drugs. 

On July 22, 2015, a Circular was issued to applicants, requiring them to conduct a self-audit and submit an electronic inspection form by August 25th. According to industry sources, this move has caught some firms by surprise. If companies are not able to comply with this mandate - or if their self-audit identifies non-compliant data - they may voluntarily withdraw their registration applications from CFDA by the same deadline. 

According to the law firm Sidley Austin, the self-inspection must include: 

  • A comparison of the locked database and original data, to look for discrepancies (any differences must be explained); 
  • Maintenance records of testing instruments (such as HPLC, LC-MS/MS);
  • Evidence of installment and operation of the audit trail module of data management software (if you're an eCOS user, you're already compliant with this one); 
  • Compliance with the inclusion and exclusion criteria for patients in clinical trials;
  • Data on clinical trial protocol deviations and exclusions, serious adverse events, information on patient visits and lab testing;
  • Records related to investigational products and comparator products, including relevant invoices, records and samples;
  • Records related to the collection, storage, and analysis of biological samples
  • Review of clinical trial protocol compliance by all parties.

The CFDA has also announced that it will conduct further verification (including unannounced on-site inspections) based on the self-inspection reports. Non-compliance could lead to a 3-year ban from filing any drug registration applications with CFDA.

If you're an eCOS customer affected by the Chinese FDA mandate, good news: Many aspects of our platform will help make your self-inspection easier. Should you have any questions, our international team is happy to talk to you! Just send an email to Simon Hawken, our Director of International Sales (Simon.Hawken@eclinicalos.com)  or David Wu, our Business Development Representative in China (David.Wu@eclinicalos.com). David is located in our Shanghai office and can communicate in Chinese, if you prefer.   

To read this blog post in Chinese, scroll down. 


 

825日前完成合规性自查

中国国家食品药品监督管理总局(CFDA)针对现有1,622个待审药品注册申请加大监管力度,以保证临床数据的准确性和药品质量(包括原始数据和记录的保存)。名单包括本地申报生产或进口待审药品。

在2015年7月22日,该项公告发布给了申请人,要求他们展开自查并与8月25日前提交电子自查表。根据行业相关反馈,这一举动震惊了许多公司。如果这些公司不能遵守这一规定,或者他们在自查中发现了不合规的数据,他们能够在同一截止日期前自愿撤回这些向CFDA提交的注册申请。

根据Sidley Austin律师事务所的信息,这些自查必须包括:

  • 核对锁定的数据库与原始数据一致性,数据锁定后是否有修改(任何修改必须加以说明)
  • 生物样本分析测试仪器(如HPLC、LC-MS/MS)等主要的试验仪器设备运行和维护记录
  • 数据管理软件稽查模块的安装及其运行说明(如果您是eCOS用户,您已经符合该项要求)
  • 临床试验受试者入选和排除标准的合规性
  • 临床试验方案违背例数、剔除例数、严重不良事件例数等关键数据,受试者就诊信息、用药及检查化验信息
  • 试验药物和对照药品的信息,包括相关票据、记录、留样
  • 生物样本的采集、保存、分析过程相关的记录
  • 有关方在临床试验项目中主要职责的落实情况、合规情况

CFDA已经通告其将基于企业自查报告自查的基础上展开进一步的核查(包括不预先通知的飞行检查)。对于不合规的相关申请人,CFDA 3年内不受理其申请。

如果您是eCOS的用户,您正关注CFDA的该项公告,告诉您好消息是我们的平台能更高效快捷地帮助您完成自查。如果您有任何问题,我们的国际商务发展团队会乐于与您沟通。您可以发邮件给Simon Hawken,国际商务发展团队VP(Simon.Hawken@eclinicalos.com) 或David Wu 中国区商务发展总监(David.Wu@eclinicalos.com),David Wu 在eCOS上海办公室办公,可以与您中文交流。

Topics: Regulations, China

South Africa's POPI Act: What Does it Mean for Clinical Research?

Posted by Dianne Chatterton on Aug 3, 2015 3:57:00 PM

The POPI (Protection of Personal Information) Act is an effort to align South African privacy laws with international standards.

9H

 The POPI Act is a hot topic right now in South Africa and stands to send waves across the world. What is it? The POPI, or Protection of Personal Information act, is a new privacy law that applies to all companies collecting, storing, or processing personal information. This includes the three tiers of government.

In addition to protecting the information they hold about people and employees, organizations in South Africa must now safeguard the information they hold about companies, business partners, vendors, suppliers, and so on. The burden of complying with the law is going to be a difficult one, in part because of the extremely broad brush definition of ‘personal information.'

Elevating South Africa to the Global Stage 

The goal of POPI is to bring a uniformed standard to South Africa in order to allow homegrown businesses to play and compete at a global level, and also attract and make it easier for international organizations to work with South African companies. The bill brings South Africa in line with international norms on the protection of data privacy, thereby allowing the flow of personal information to South Africa from other nations with data protection regimes. This is particularly important for services such as data or call center outsourcing and IT software solution providers who host such information in South Africa for foreign organizations. However, local organizations with foreign operations must take heed of the data protection regulations in those foreign jurisdictions to ensure they comply when exchanging customer or employee information with South Africa.

Quick Enforcement Timeline

Another big takeaway for businesses handling PI in South Africa is that organizations are expected to be fully compliant with the new bill within one year of its enactment. This poses a particular challenge, not necessarily from an infrastructure perspective, but for employees who are going to have drastic changes in the way this kind of information is handled. With punishments being steep - involving fines, and even (in some cases) jail time, training employees on standards and practices for the new legislation will be crucial to successful POPI compliance.

eClinicalOS, Patient Privacy, and the POPI Act

As an Electronic Data Capture system for clinical research, eClinicalOS handles large volumes of patient information. This puts eCOS at the center of discussions on the protection of personal information. Having been involved in high-level security measures since the company's inception, Anu Virkar, VP of Quality and Compliance at Merge Healthcare’s eClinicalOS division, thinks eClinicalOS’s compliance with POPI will not require any changes to our systems and procedures, as we are compliant with some of the most stringent global legislation.

 “We have ongoing PHI (personal health information) and PII (personally identifiable information) internal staff training to the highest standards,” said Virkar.  “In addition to the US and FDA Part 11 standards, the EU’s “Annex 11” law has in place some of the strictest privacy standards for personal information in the world. Places like India, Germany, Brazil and now China and Japan have very rigid standards of retention and sharing of PI, and we are compliant with all of them."  

Virkar also added, “eClinicalOS will have no problem complying with POPI, and can even consult with partner organizations in the steps to become compliant.”

Have questions about the POPI act (or other data privacy and security issues)? Contact us!

 


 

If you're not an eCOS user yet, get more information and sign up for your personal tour below!

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Topics: South Africa

The Top 4 Emerging International Markets for Clinical Research

Posted by Amy Young on Jul 31, 2015 1:58:00 PM

map

 It’s no secret that clinical trials are a world-wide operation. Which markets are the hottest right now?

A recent analysis found that from 2007 to 2011, the number of clinical trials registered in emerging countries went up, while the amount of studies registered in the United States and Western Europe experienced a decline.

Wondering which regions and countries are trending these days? Here’s a breakdown:

1. Asia-Pacific

Asia-Pacific is home to two-thirds of the world’s population and offers many advantages, such as quicker patient recruitment, streamlined study start-up, and cost savings. The region has a diverse number of disease states and therapeutic conditions compared to some other markets, especially in infectious disease.

In this part of the world, China, India, and Korea are the fastest-growing settings for clinical trials. (In fact, we've written extensively about the advantages - and cautions - of conducting research in China.)   

Plus, for a variety of reasons, South Korea is emerging as a popular destination for early phase clinical trials (along with China, Russia, Australia, and Singapore). 

The increased interest in Asia-Pacific is driving an improved clinical research infrastructure in many of the region's countries. While the most action is happening in China, countries such as the Philippines, Thailand, and Indonesia are also experiencing growth. 

2. Latin America

By some estimates, trials in Latin America cost 30 percent less than those in the United States or Western Europe. This is attributed to easier patient enrollment and retention because of the region's treatment-naïve patient population and concentration of people in large metropolitan areas.  Notable trending countries in the region include Guatemala, Ecuador, and Panama.

3. Central and Eastern Europe

In Central Europe, the countries of Bulgaria, Czech Republic, Hungary, Poland, Romania, and Slovakia are becoming magnets for clinical researchers, with growth there estimated at nearly 10% over the past few years

In Eastern Europe, Russia remains an attractive location for clinical research, despite what some claim is a challenging regulatory environment. Over 3,000 trials are ongoing in Russia in 2015, up from 2,700 in 2012.

Industry leaders name the prevalence of centralized health systems and improved healthcare infrastructure as the reason for the growth of global studies in this region.  

4. Africa

While Africa may not be the "hottest" clinical research destination, interest is growing - especially in South Africa. There, the number of registered studies has grown from 1,600 in 2013 to nearly 2,075 in 2015. According to South African researchers, the country's genetically diverse population, good exchange rate, high burden of traditional and lifestyle diseases, and well-established research infrastructure make it a good place to do clinical trials. 


Doing business with the world? Make sure you have the right technology. 

There's a lot to think about when conducting research on a global scale: logistics, language barriers, regulatory concerns, and the list goes on.  But have you thought about your EDC system? You should.  

At eClinicalOS, we've designed our platform to be a true world player. How? Well, not ony do we offer on-the-fly translation within the system in more than 80 languages, we also provide customer support 24/7/365 to account for every time zone. Plus, our (extremely busy) regulatory department stays on top of rapidly changing rules and regulations in the more than 80 countries currently using our platform.  

If you're not using the eCOS system yet, why not give it a test drive?  We'll be happy to show you how it all works, including how you can use the system to conduct resesarch in every country and every time zone, all over the world.   

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Topics: Clinical outsourcing, international growth

Happy Birthday eCOS! A Look Back at Our 3rd Year

Posted by Sean Farres on Jul 28, 2015 12:54:08 PM

This summer, eClinicalOS (eCOS) celebrates 3 years in business!

It's hard to believe we've grown to over 500 active trials in just 36 months. (We like to think we're pretty advanced for a 3-year-old.) 

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To mark the occasion, we're taking a look back at the system improvements we've made since our second birthday just one year ago. Here's what's new since Summer 2014:

Advanced Expression Editor (New v5.6.1.0)

  • Visual, drag and drop expression builder
  • Used with Cohorts, Dispense (V2), Migration Tool
  • Continuously amending new operators, new functions, new applications
  • Used to build Alert triggers, System Queries and auto-calculated fields

Ad-Hoc Reporting Enhancements

  • Advanced filtering, reactive search and page browsing
  • New reports added bi-monthly 

Newly available reports include:

Interactive Web Response (IWR)

Endpoint Adjudication Enhancements 

  • Dedicated set of reports (including the highly flexible Adjudication Data Tracker allowing the user to pick any data/status/info from adjudication visits and others)
  • Disagreement Resolution process (auto-loop, highlight disagreements)
  • Automated EAM status jumps in case of disagreement to streamline the processes and limit required actions from Adjudication Coordinator
  • Additional EAM Status  (to handle specific scenarios as ‘In Query,’ v2015.5.0)

Enhancements to CTMS for Investigators

Study Connect App (updated May 2015) 

  • Original capabilities: Study Alerts – Adverse Events, New Site/New Patient Enrollment, Subject Status Changes
  • Added capabilities include: Randomizing, Dispensing & Inventory Management, Unblinding

Medical Coding Enhancements (updated Nov 2014, March 2015) 

Support Services (updated Jan 2015)

  • New comprehensive knowledge base, completely searchable
  • Updated online user manual
  • Ability to submit requests and inquiries

Visit Time Window concept added (v5.6.4.0)

Revised Inventory Dispensing with Bulk Dispense (v2015.6.0)

Site Management Upgrades (v2015.6.0)

  • The Import Site and Site Management tools are being combined for better access and to allow for new tools. 

..And the improvements keep on coming!  We're constantly enhancing the platform thanks to the feedback of our customers.  We couldn't have made it three years without you. So...thank you, thank you, thank you! (That's one thanks for each year!)

We look forward to many more years of bringing you the very best cloud-based EDC and CTMS in the business! 

(Oh, and if you're not a customer yet, we'd love to show you around!  Click below to schedule your personal demo of the system.)  

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Topics: EDC, ctms

La Jolla: It's pronounced "La Hoya." Meet us there Thursday!

Posted by Greg Pack on Jul 20, 2015 3:01:48 PM

Join us this Thursday, July 23rd starting at 4 PM, for our west coast user networking event in Southern California! The event will be hosted at Eddie V’s restaurant in La Jolla, nestled along the breathtaking waterfront cliffs overlooking the Pacific Ocean. Our President, Zaher El-Assi (@zelassi) will be in the house as well, for a night of Cocktails and hors d’oeuvres.
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This event will provide an opportunity for some of our users and those interested in learning more about eClinicalOS and to ask questions and interact with some of the faces behind our award-winning cloud-based electronic data capture (EDC) system.

  RSVP Now!

If you would like to attend, or have questions, please contact Adam Noe for additional details.

• Email: adam.noe@eclinicalos.com
• Mobile: (312)550.3525 Twitter:@adamnoe

 

 

Heard of mHealth? Now there's mResearch!

Posted by Amy Young on Jul 17, 2015 10:55:00 AM

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As we discussed in our DIA wrap-up last month, mHealth (mobile health) is a topic on everyone's lips. 

From basic nutrition and exercise apps to sophisticated devices capable of measuring glucose levels through contact lenses, the healthcare universe is charged with excitement over the potential this technology offers. 

But beyond the buzz lies a sobering reality: widespread adoption of mHealth will take time. And the true benefits to clinical trials may take even longer. An industry survey reveals that 80% of clinical researchers think the use of mHealth is still in its infancy. 

Introducing mResearch – available now!

Apple made news this year with their ResearchKit, a platform designed to help doctors and researchers gather patient data more frequently and efficiently. It also shows promise for expediting patient recruitment.  At its heart, however, ResearchKit is basically another mHealth technology subject to the same concerns we mentioned above. 

Enter the Study Connect Mobile App from eClinicalOS. It's distinct from traditional "mHealth" in that it doesn't collect data – instead, it helps you manage and track it. Through any smartphone or tablet running iOS, you can get the most up-to-date information on your studies — from anywhere, at any time. That's why we say it's mobile research (mResearch) in its purest form. 

With Study Connect, you can quickly and easily:

  • Manage randomization of subjects.
  • Coordinate dispensing and inventory management.
  • Unblind individual subjects, as circumstances warrant.
  • Stay connected with real-time customized notifications. (For example, find out immediately when a subject experiences an adverse event.)
  • Monitor enrollment and establish milestone alerts.
  • Share top-level statistics for each study with key stakeholders using the study dashboard.
  • Expedite approval response times for critical study decisions such as patient study eligibility.
  • Maintain security with the ability to set customized role-based permissions for individual studies.

Managing your study from your desk is so 2014. Read the full description of Study Connect at the Apple Store and get ready to join the mResearch revolution! 

Activate Study Connect and get a free Apple Watch! 

For a limited time, when you activate Study Connect AND have at least one user access their study within the mobile app, we'll send you a free Apple Watch!  Get all the details and register now.

Register for our Study Connect Offer!

Also, don't miss our free webinar on Study Connect, coming up next week. Join this open attendance presentation for a deeper dive into everything you can do with the app! 

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Can you really cut your clinical study build time in half?

Posted by Amy Young on Jul 13, 2015 4:57:00 PM

Yes. Here's how to start chipping away at that $1 billion price tag for drug development.Time

Everywhere you look, clinical research professionals are talking about efficiency.  Heck, even the government is getting in on the movement. The reasons are obvious: Less time spent on a clinical trial means fewer expenses and a quicker path to market. And with the cost of drug development estimated at $1 Billion, a growing chorus of industry voices agrees that expediting the process is an imperative.

Ok, great. But WHERE do you begin to cut that time? The answer may lie in the cloud - your cloud-based electronic data capture (EDC) system, that is. If you're an eClinicalOS (eCOS) user, you can experience a study build measured in days, not months.  

Recently, our VP of Operations, Isaac Erickson, and Implementation Team Manager, Mark Laney, produced a free webinar outlining strategies for reducing study build time with our platform.  

As they explained, standard build time in the industry is about 12 weeks. But we think we you deserve better than that (a lot better!). That's why we have a plethora of tools that enable us – and you – to move faster.

Here's the top five tools, tips and tricks that can help you cut your study build time by up to 50%:

1. Study Library 

The study library is a collection of standards that you've previously agreed to, to create a dummy study that you can constantly reference from. Once standards are agreed upon and put in place, building subsequent studies will be much, much faster. 

2. Importing 

Our system allows importing of a wide variety of study components. You can copy a full study and use it to build another one. You can also copy and import queries, CRFs, permissions and rules, and more. Our customers find it to be a whole lot faster than starting from scratch! 

3. Visual Design

We try to make the design process as visual as possible. Visual design means that you spend less time working out some theoretical piece-of-paper specification and more time actually looking at what we're all talking about. We find that utilizing visual design drastically reduces the amount of time everyone spends discussing what something "might" look like or how something "might" behave.

4. Time-saving design tools

Based on our experience (and extensive user feedback), we've designed the functionality of our design tools with efficiency in mind. Our simple queries, basic query designer, and advanced expression editor can all make the study build process much quicker (and much less of a hassle!).

5. Testing efficiencies

We have a unique solution to change requests that has proved to be a huge timesaver. Our change request module automates many steps of the process. So far, we've found that it has allowed us to go from an average of 7 UAT (user acceptance testing) iterations, to less than 3. That's huge! 

Interested in learning more? We have a webinar for that! Download "How to Cut Your Study Build Time in Half," watch at your leisure, and get all the details. 

Not an eCOS user yet? It's time to change that. Get started by requesting your demo now! 

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Equal Opportunity Electronic Data Capture

Posted by Amy Young on Jul 1, 2015 12:09:00 PM
EDC is for you – even if you have 3 employees and an "office" in your basement.

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This coming weekend, the U.S. celebrates the founding of our country. America is often called "the land of opportunity" – a place where anyone, regardless of background, can succeed through hard work and determination.  At eClinicalOS, we apply those same principles to the design of our data management solutions. Whether you're a large multinational corporation or a fledgling start-up, we think your clinical study deserves the advantages offered by cloud-based software.

How do we make EDC available for all? By eliminating expensive up-front contracts. By offering flexible, pay-as-you-go, module-based pricing. By drastically reducing timelines with a study build measured in days, not months.  

Recently, our president, Zaher El-Assi, wrote an article for Applied Clinical Trials explaining our founding philosophy. In Removing Barriers to Affordable, Accessible, and Effective Electronic Data Capture, he reveals why we believe EDC benefits are no longer limited to the big players. Check it out!   

This year, you don't have to be an American to celebrate equal opportunity for all. Let freedom ring! 


To learn more about eClinicalOS, sign up for a FREE sandbox today! 

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Topics: EDC, edc adoption

eClinicalOS v2015.6.0

Posted by Dianne Chatterton on Jun 29, 2015 3:30:00 PM

We are pleased to announce the release of eClinicalOS v2015.6.0 on Friday, July 17, 2015.  

eClinicalOS v2015.6.0 includes information on Site Management Upgrades as well as some other enhancements to existing tools.

Here are a few highlights in the upcoming release:

Revised Inventory/Dispensing with Bulk Dispense

The Inventory/Dispensing Management module has been updated to include new interface and to prepare for further future enhancements. Along with the visual changes, the backend support has been updated and a new tool has been added. The new tool allows for multi-component packages to be shipped, tracked, and dispensed, including dispense to multiple subjects. NOTE: Existing studies should remain in the current module version to preserve function and output.

Site Management Upgrades

The Import Site and Site Management tools are being combined for better access and to allow for new tools. These changes are found in the designer only but the core functionality remains the same in both designer and EDC. In addition to importing from other studies and from a spreadsheet, the spreadsheet upload can also be used to update the existing sites. An email site option has also been added, to make blast emails easier on your studies.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@eClinicalOS.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, EDC, Site Management, Dispense

All the Buzz from DIA 2015

Posted by Amy Young on Jun 26, 2015 11:28:00 AM

Five headlines from the industry's biggest gathering 

DIA_scene

There were over 245 forums, sessions, and workshops at DIA 2015, and collectively, the eClinicalOS team attended more than 30 of them. (We haven't quite perfected that cloning thing yet, otherwise we would have gone to every one!) The topics, speakers, and questions were wonderfully diverse and informative. But if we had to sum up the themes of the show, we'd say these were the 5 biggest takeaways: 

1. mHealth is mHuge – But there are caveats

mHealth is far and away the hottest topic of the year. No wonder: By 2020, the wearable electronics and technology market is expected to be worth about 12 Billion.(!!) A variety of devices and apps are capable of measuring movement, sleep patterns, breathing rate, skin temperature, and more – allowing researchers to collect and manage trillions of new data points more efficiently than ever before. What's more, wearables have the potential to create completely new endpoints in clinical trials. For example, they could measure the amount/frequency of scratching in eczema patients, a metric for which there is no current objective method of data collection. 

But with new tools come new questions:  How can we standardize these collection devices so that they are accepted across the industry? How will they be calibrated? What about patient compliance? Can they be integrated with other electronic systems? And (this is a big one) how will we protect privacy? These issues and more will need to be worked out before we can truly reap the benefits of the transformative innovations before us. 

What about mHealth regulation? We learned that medical apps are not considered to be medical devices, therefore the FDA does not regulate them. Some mobile apps may meet the definition of a medical device, but because they pose a lower risk to the public, the FDA intends to exercise “enforcement discretion” over these devices. (This is all subject to change, of course, as the technology advances.) 

2. The patient is king. 

Patients nowadays are taking their health into their own hands. And it's more than medical apps and wearable devices; it’s also the rise of communities. Thanks to the internet, patients can instantly collaborate with others who share their condition - and mobilize to help find a cure. According to numerous industry experts, in the future, patients will have a say not only in research topics and but also in trial protocols. Patients want to participate in the process, not simply be experimented upon. Their voices are growing louder that ever before. Case in point: “I am not a lab rat” is a trending hash tag. 

On June 15 (coincidentally, the first day of the DIA conference), the FDA made news by announcing a research collaboration with Patients Like Me, an online patient community with over 350,000 members. The project will explore how patient-reported data can give new insights into drug safety. I think we can safely say that the era of the patient has arrived! 

3. "Big data" is only getting bigger. 

Speakers throughout the sessions agreed: What we consider "big data" today will be “small data” just 2 years from now. Wearables are one source of new data: By some estimates they can capture up to 2800 data points in a day. But industry experts are encouraging researchers to think bigger. What about sources of data beyond the "traditional?" Drug stores know how many people are taking which drugs. Diagnostic labs have all the data on test results – how many are normal, how many are not. Insurance companies and EMR systems are also massive sources of data. What if we could leverage all of this with the cloud?  The possibilities are mind-boggling. 

4. Biomarkers* are changing the game.

Experts agree: Biomarkers will drive the era of personalized medicine. Because every person is unique, everyone’s response to a medication may be different. More than half of clinical trials already have a molecular biomarker component. If we stratify patients to identify population subsets most likely to respond to a therapy, we can get therapies to market with a much smaller patient pool and in a much faster time frame. It's already happening:  One medication was able to gain approval with just 132 patients studied!

5. The end of paper is near.

These days, paper processes are disappearing at a breakneck pace, even amongst the smaller players. And soon, the days of hiring a u-haul to submit your trial data to the FDA will be completely over. In May 2017, the FDA will require eCTD (electronic common technical document) to submit the following:

  • Certain investigational new drug applications (INDs)
  • New drug applications (NDAs)
  • Abbreviated new drug applications (ANDAs)
  • Certain biologics license applications (BLAs)

Of course, we've really only scratched the surface with this list. I think all 6,000+ attendees at the conference would agree that we are fortunate to work in such a fascinating industry with such a vast array of potential. As keynote speaker Daniel Burrus said at the opening plenary session, "We live at a unique time in history. We're standing at the base of a mountain of innovation. The world needs you!" Indeed.  

 Keynote-1

*What are biomarkers? They're biological molecules, found in blood, other body fluids, or tissues, which are a sign of a normal or abnormal process or of a condition or disease. A biomarker may be measured by a diagnostic test to predict if the body will respond to a treatment for a disease.

Keep up with all the latest industry news! Check out our available White Papers and eGuides.

 

 

DIA 2015 Post Show Recap: The eCOS Effect

Posted by Greg Pack on Jun 24, 2015 3:18:00 PM

 DIA_Annual_Meeting

One of the year's most anticipated Clinical Research industry tradeshows, the DIA 2015 51st Annual Meeting, was held in Washington DC last week, and from the outset, eClinicalOS's eClinical division truly painted the show orange. 

Each year, the Drug Information Association (DIA) national conference brings clinical research companies and professionals together to learn about industry trends, innovations and solutions. There were more than 100 educational sessions for attendees to choose from at this years conference, and over 450 companies exhibiting on the trade show floor. 

Develop. Innovate. Advance.

As the show opened, several members of our team attended sessions on topics ranging from personalized medicine to mHealth and Big Data. "The best part for me was hearing from people in all facets of clinical research: CROs, AROs, Sponsors, the FDA, Tech Companies, and even patient advocacy groups," said Amy Young, Senior Writer for eClinicalOS (@ecos_amy). "By attending the sessions, you truly had your finger on the pulse of the clinical research industry and what is happening right now."

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At 6:00 Monday morning (and despite stifling heat and humidity), more than 20 dedicated eClinicalOS team members joined hundreds of other life science professionals in Mount Vernon Square to participate in the Medical Heroes walk/run. The preconference event was held to raise money and celebrate the people who give the gift of participation in clinical research. Proceeds from the run/walk went toward a great cause: providing education and outreach to patients and their families. 

The eCOS Effect

The show also marked the release of our new mascot, eCOS, a butterfly-esque creature. eCOS is not your standard-issue butterfly. It’s evolved to the next level of “butterfly-hood,” offering a host of new skills, talents and abilities. In the clinical research industry, it’s survival of the fittest. And just as eCOS the butterfly has evolved to have special powers, so too has our eCOS platform. An 8-foot-tall likeness of eCOS was the centerpiece of our booth this year.

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As attendees and exhibitors poured into the Walter E. Washington Convention Center, it was clear that the eCOS effect had taken over. The crowd was greeted with leader boards, Twitter boards, escalator banners, and quite possibly one of the more unconventional booths ever imagined, all adorned with our cuddly creature. 

Throughout the 3 days of the conference, over 1000 people came through the booth to collect goodies, take selfies with eCOS, and learn about our platform. Our team also met with hundreds of friends and partners in the industry. (To be honest, we are just now getting our voices back!) 

Noteable Quotes from our Staff and Clientele

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"Best DIA Conference in years."

"eClinicalOS stole the show. Had the most unique display, tremendous activity at the booth, amazing buzz – everyone was talking about (eClinicalOS), even cute little eCOS!"

"Lots of interest in our products and many customers ready to take the next step."

"Snoooooooooooooooop!"

Last, but not least, how many people can say they attended an industry conference featuring a Snoop Dogg performance? 

Snoop_Dogg_DIA_2015

On Monday night, one of our valued vendors, Transperfect, put on a party themed "Tomorrowland," at the National Building Museum. Rumors were flying around all day that a very special guest would be perfoming. Sharply at 10:49pm, Snoop Dogg walked out on stage to a thunderous applause from the large crowd. He launched into a set of his greatest hits, and even slipped a few cover tunes in to please the crowd. After performing for almost an hour, we can say for certain that we all had a blast – and learned Snoop's take on Clinical Research. (Hint: He's a proponent of "natural healing.") 

All in all, we had a fantastic time attending and exhibiting at the show this year, and look forward to a bigger and better showing in Philadelphia in 2016. We hope we see you there!

 

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Topics: DIA

Continental Shift: eCOS Goes to South Africa

Posted by Amy Young on Jun 22, 2015 4:30:00 PM

Fresh off eClinicalOS’s recent international successes at DIA China and OCT Europe, three eClinicalOS Team Representatives traveled a combined 13,000 miles to present at the South African Clinical Research Association’s (SACRA) June breakfast meetings.

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In Midrand, Johannesburg on 5th June and Cape Town on the 12th, eClinicalOS president Zaher El-Assi addressed over 100 attendees. Audience members included global and local pharma, international and local CROs, and several Academic Research Organizations (ARO).

Mr El-Assi spoke on the arrival of “Big Data” in clinical trials, and explained how in time, new mHealth devices for data collection could be adopted by the South African market.

A hot topic raised by attendees was the introduction of South Africa’s Protection of Personal Information Act (POPI). Due to be implemented later this year, the act seeks to regulate the processing of personal Information, aligning it with other global players in the industry. Many are comparing it to the UK Data Protection Act and the US HIPPA laws (both of which are supported by the eClinicalOS platform).

Over the course of 10 days, eClinicalOS eClinical visited clients in Johannesburg, Pretoria and Cape Town, and introduced eClinicalOS to new players in the market. Having had a presence in South Africa for a number of years, the system’s flexibility and scalability continues to grow in popularity.

“With its population diversity, low costs, and large number of sites, the South African market offers a unique opportunity for clinical research," said Mr. El-Assi. "We were thrilled to be invited to speak by SACRA, an organization widely considered to be the true face of CRO and researcher collaboration in South Africa. I'm excited to continue to grow our presence and reach in the region." 

Already looking ahead, eClinicalOS eClinical has been asked to speak at SACRA’s bi-annual conference, due to be held Autumn 2016. As the locals say, see you now, now South Africa!

For more information about our platform, or to take our system for a test drive, sign up for a sandbox or take a demo with one of our platform experts.

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Topics: Big Data, SACRA, POPI

Your Time at DIA is Limited. Here's How to Make the Most of It!

Posted by Amy Young on Jun 11, 2015 11:16:00 AM

Excitement is building. 

It's hard to believe, but just a few days remain until the DIA Annual Meeting in Washington, D.C.!  As you can imagine, things are moving fast here at eClinicalOS headquarters in Morrisville, NC. Our team has been prepped, the materials are ready, and travel plans are set. Just wait until you see our booth (Trust us, you won't want to miss it!).

We've been looking over the conference schedule and it's packed full of interesting, engaging sessions – not to mention hundreds of exhibitors. Clearly, there will be a lot of noise and activity competing for your attention; but even if you only have a minute or two, we hope you'll stop by booth #2209!  (Want to set a meeting with us in advance? You can do that here.) 

DIA_Annual_Meeting

Got 30 seconds?

You can take a selfie with eCOS, our somewhat unconventional mascot. eCOS echoes “The Butterfly Effect” in which a butterfly’s wings (i.e., small events, small features) have major impact around the world (kind of like our product!) We'll email you the picture, and you'll walk away with a super cute souvenir keychain. 

Have a minute?

Participate in our trends survey. Lend us your opinions and we'll give you an eCOS USB loaded with an EDC industry intel and comparison report. Did you know that EDC adoption has risen from 77% to 91% in just two years? And that most companies say cost is the #1 driver of their decision? Read the report to find out how companies like yours are managing study data in 2015.

Spare 5 minutes?

Experience eCOS in action by participating in a demo of the system. Our solution is truly unique in the industry and we think you'll like what you see!  When you do, we'll send you away with a gift bag loaded with every promotional item we're offering!  

A few (ok, 7) final words of advice before you leave:

Pack lightweight clothing: The weather looks to be hot. (But bring a sweater for sometimes-chilly meeting rooms.)

Wear comfortable shoes if you can!  There are 450+ companies in the exhibit hall – that’s a lot of walking!

Driving to DC? Dianne, our resident expert, says to leave early. Traffic around the nation's capital moves slower than congress some days…

Try some 2-wheeled transportation! Get around traffic jams with Capital Bikeshare, Washington D.C.'s short-term bicycle rental program. The first 30 minutes are free and there are 350 stations across the region! 

Need to get some exercise? Join us for the Medical Heroes Appreciation Run/Walk 5k on Monday. It starts at 6:45 am next to the convention center.

Post and read about the show on social media channels: Use the hashtag #DIA2015.

Download the DIA app to keep up with conference happenings in real time. Just search “DIA Global” in the app store and sign in with the email you used to register for the conference. 

See you in D.C. on Monday! 

  schedule my personal demo

Switch to Success: There’s a Better Way to Manage Your Clinical Trials

Posted by Amy Young on Jun 10, 2015 9:05:00 AM
Rescue your trials by migrating your studies to eClinicalOS! 

Are you less than thrilled with your current EDC system?  We understand your frustration. We've heard from lots of researchers who tell us they're paying too much for systems that don't deliver and are backed by vendors with questionable staying power. 

eClinicalOS (eCOS) can cross those worries right off your list. 
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What is eCOS? It's the fastest-growing cloud-based EDC on the market today. CROs and Sponsors love our modular, scalable platform and attractive pay-as-you-go pricing. 

When you migrate your studies to eCOS, you can:
  1. Reduce the overall costs of conducting electronic clinical trials by up to 50%.
  2. Become more efficient and productive than ever before.
  3. Make more money.

The Deal is On!

From now until June 18 (the final day of the DIA 2015 Annual Meeting in Washington, D.C.), we’re offering a bold, cost-savings deal that we guarantee you’ll want to take advantage of.

We are hosting a webinar on Thursday, June 11th at 12:00 p.m. EDT to give you all the details. Platform experts Isaac Erickson and Mark Laney will discuss the benefits of converting your study to eClinicalOS, share the streamlined process we use to migrate your study, and offer real-life testimonials from customers who've made the switch! Register today to learn more about this deal! 

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Topics: EDC, clinical trials, Webinar, migration

PCMG Conference Highlights Outsourcing Solutions in Clinical Studies

Posted by Greg Pack on Jun 3, 2015 2:09:00 PM

 

PCMGNext week, June 10-12, we are pleased to announce that several members of our eClinicalOS will be attending the Pharmaceutical Contract Management Group (PCMG) conference in Warsaw Poland! 

The theme of this years PCMG conference is “Risk, Complexity and Compliance,” and will touch on several hot industry topics related to Clinical Research and outsourcing solutions, including:

  • Investigate the reality of Risk Based Monitoring
  • Examine the value of Key Personnel in successful outsourcing
  • Look down into the innovations of the London Tube reformation
  • Prepare to debate the role of Procurement vs. CRO Relationships
  • Challeng how complexity in clinical development is managed
  • Shine a light on vital aspects of compliance in clinical studies and outsourcing implications

We are excited about this year’s agenda which will touch on not only on core outsourcing issues, but operations and finance issues and communication strategies. These are areas that eClinicalOS can have a high impact on your clinical research trials. 

For more information about our award-winning clinical trials electronic data capture (EDC) platform, or to get in contact with a staff member, click here. To request a meeting or a demo with a member of our team, click the "Schedule a Demo" link below.

For more information on the conference, please visit the official PCMG Website by clicking here, or email admin@pcmg.org.uk for more information.

Hope to see you there!

eClinicalOS Team

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Topics: Trade Shows, EDC, Clinical outsourcing, clinical research, PCMG 2015

It's Almost Here! DIA Promises to be Amazing

Posted by Amy Young on Jun 2, 2015 9:30:00 AM

DC-1Is your work life like ours right now? And by that I mean insanely busy? Meetings, deliverables, and to-do lists are increasing at warp speed as we approach the industry's biggest U.S. event: The DIA Annual meeting in Washington, D.C.  But as crazy as things seem right now, we can't wait to show off what we have in store! 

We may be a little biased, but we think Booth #2209 is going to be the meeting's biggest draw.

Why?

It's all down to our product: eClinicalOS (eCOS). Our booth this year will highlight all the ways our flagship platform has grown and evolved - all while maintaining a laser focus on our biggest goal: Helping clinical researchers save time money, and hassle. (Hint: We're calling it the "eCOS Effect" for a reason.)

When you visit us you can:

  • Check out our brand new mobile app! (It's unlike any you've seen before, we promise.) 
  • Demo the system! (See our platform in a real-world environment!) 
  • Find out how you can save up to 50% on the cost of EDC! (Really!) 
  • Get great giveaways! (When you demo the system, you get all sorts of fun stuff, including a research report on the state of EDC in 2015!)

If nothing else, we hope you'll stop by and say hello. Our full team will be in attendance, and we're really fun to talk to. (Come commiserate on how crazed your life is right now! We feel you.) 

Meet us June 14 - 18 in the nation's capital, and find out how eCOS can help your trials take flight! 

Like to schedule a meeting ahead of the show?* You can do that here.

*Good plan. It's going to be busy in the booth!  

We hope to see you there! 

Topics: DIA

DIA China Post Conference Wrap up: A Beacon of Light

Posted by Greg Pack on May 28, 2015 3:55:00 PM

Yesterday concluded the DIA China 2015 conference in Shanghai, China, which was a huge success for eClinicalOS and also for our customers and partners. The number of attendees at the conference was high, with global pharma, local pharma, international and local CROs and several Academic Research Organizations (ARO) all represented.China_DIA_31

Themes at this year’s show revolved around the expansion of the Chinese market for Clinical Trials, particularly how it is beginning to implement best-in-class technology and processes to support clinical development.

That's exactly where the eClinicalOS EDC platform (eCOS) comes in!

“Without exception, when we showed eCOS we received hugely positive feedback on the user interface, functionality, and ease of use,” said Simon Hawken, Merge eClinical’s Regional VP. “And then we showed how easy it is to switch the operating system language into Chinese - and they were even more impressed!”

Next up for the eCOS team is a trip down to South Africa for South African Clinical Research Association's (SACRA) annual breakfast, where Merge eClinical's President, Zaher El-Assi, will be speaking about industry trends and the subject of "big data."

Merge eClinical is also gearing up for a huge presence at this year's DIA 2015 conference in Washington D.C. June 14-18. You can catch up with our team at booth 2209. 

For more information on the rapid growth of China's Clinical Research industry, download our free whitepaper. Or, if you'd like to schedule a demo, you can do that too! 

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Topics: clinical trials, DIA

OCT Europe 2015 and the eCOS Effect: A Post Conference Blog

Posted by Greg Pack on May 26, 2015 5:00:00 PM

IMG_0012In addition to attending outstanding sessions and forums last week at the 2015 Outsourcing in Clinical Trials (OCT) European forum in Dusseldorf, Germany, attendees were treated to a preview of our new mascot, eCOS! eCOS represents our ease of use, transparency, and unified vision. The “eCOS effect” is an evolution that can help trials take flight. 

With last year’s conference achieving record results, we were eagerly anticipating attending this year’s event. Speaker topics covered outsourcing issues of all kinds, ranging from operations, finance issues, patient perspectives and communications strategies. eClinicalOS eClinical’s Antonia Hawken led the Wednesday Spotlight Session and discussed “Managing Risk on the Go: Why Regulatory Policy Shifts Demand 24/7 Trial Access.” and members of staff were on hand to demonstrate our award-winning clinical trial management platform.

Next up for the eClinicalOS eClinical Team will be DIA 2015 in Washington DC. Come see us at booth 2209 and take our system for a test drive! We hope to see you there! 

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Topics: OCT2015

DIA China Conference May 24-27: Asia's Largest Clinical Research Event

Posted by Greg Pack on May 21, 2015 9:00:00 AM

On May 24th through 27th, members of the eClinicalOS eClincalOS team will be attending the DIA China PSD-CHINALANDINGPAGEconference, “Innovation and Convergence- Building Sustainable R&D Ecosystem”, the largest multidisciplinary event in Asia, held at the Shanghai International Convention center (SCHICC) in Shanghai, China 

Fostering Innovation

China is rapidly becoming a big player in the world of clinical research, and this conference is making a strong effort to address the needs of domestic drug companies with global aspirations. The DIA China meeting will bring together professionals from all over the world to foster innovation and promote a sustainable research and development ecosystem. The ultimate goal? Accelerated development of safe and effective medical therapies for medical products and therapies for patients, both domestically in China and worldwide.

Former FDA Chief to speak

Not to be missed will be Dr. Margaret Hamburg, the FDA commissioner from May 2009 to March 2015, who will deliver a keynote speech.

Come See Us!

If you plan on attending, please stop by Booth #B09 and say “Ni Hao!” There will be several members of the eClinical staff on hand to discuss new innovations in clinical trials management and provide quick demos of our award winning clinical trials management platform.

For more information on DIA China’s 7th Annual Meeting, Click here


You may also be interested in one of our latest eGuides,"Five Proven Ways to Gain Cultural Confidence in China's Life Science Market" Download it now!

Download eGuide Now!

Topics: Trade Shows, clinical research, DIA

eCOS Celebrates International Clinical Trial Day with Big Announcement

Posted by Greg Pack on May 20, 2015 4:11:00 PM

Clinical trials have come a long way.

It all started in the seventh century BC when King Nebuchdanezzar conducted the first-ever recorded study. In short, it examined the effect of vegetables on a warrior’s health and fighting ability. Some 2300 years later, British-based Dr. James Lind held the first controlled trial in 1747 in which he explored scurvy. Two centuries later, Sir Geoffrey Marshall conducted the world’s first controlled randomized study.

Today, according to clinicaltrials.gov, there are more than 190,000 trials going on around the world!

Where do we go from here?

Increasingly, the answer is data. More specifically, mobile data. With mobile technologies being brought into the medical world, doctors can now learn all about their patients ­– in real time. We can monitor a patient’s sleep habits, blood pressure, activity levels, and as the technology improves, you can bet that we will be able to dive much deeper into health information. These healthcare mobile apps, devices and solutions are referred to as “mHealth.” (go ahead, search #mHealth on twitter right now…)

And now, we’re excited to announce mobile management of your study data!
StudyConnect_AppleWatch

eCOS users, rejoice! You can now get mobile access to your study data using our Study Connect app. While other platforms are just now switching to cloud to improve user access (eClinicalOS eClinicalOS has been cloud based for years), we are pleased to announce this true mobile technology (mHealth) improvement to our clinical trial management platform. Unmatched in the industry, the Study Connect App is just another way we are putting control of studies in the hands of the user, and living up to our reputation as one of the most innovative companies in the world today.  

Designed to work on both the iPad™ and iPhone™, the app can be integrated into existing trials through the Clinical Configurator, our exclusive online tool for the planning and budgeting of studies on the eCOS platform.

 

Seamlessly integrated with eCOS, Study Connect™ allows you to:

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  • Manage randomization of subject assignments.
  • Coordinate dispensing and inventory management.
  • Set up customized alerts for specific events.
  • Unblind individual subjects, as circumstances warrant.
  • Stay connected with real-time customized notifications such as adverse events, enrolled patients and site status changes.
  • Share top-level statistics for each study with key stakeholders using the study dashboard.
  • Expedite approval response times for critical study decisions such as patient study eligibility.
  • Monitor enrollment and establish milestone alerts.
  • Maintain security with the ability to set customized role-based permissions for individual studies.

All from a mobile device! 

For more information about Study Connect, click here

Study Connect App  

Topics: cost savings, Apps, EHR, mHealth

Heading to Dusseldorf for Outsourcing in Clinical Trials 2015?

Posted by Greg Pack on May 13, 2015 4:39:00 PM

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Next week, May 19-20, we are pleased to announce that eClinicalOS eClinicalOS will be the official Technology Sponsor of this year’s Outsourcing Clincal Trials Europe (OCT) conference in Dusseldorf, Germany! As Technology Sponsors, we will be hosting a 15 minute technology showcase on Wednesday, May 20th at 2:45 p.m.

In its 6th year, the conference is expecting record numbers of attendees and exhibitors, with hundreds of industry leaders in attendance.

We are excited about this year’s agenda which will touch on not only on core outsourcing issues, but operations and finance issues and communication strategies. These are areas that eClinicalOS has a high impact, and our team on hand will be able to answer any questions you may have about these important issues, and also offer tips and tricks to facilitate successful outsourcing of your trial. Stop by booth #4 and say “Guten Tag!” 

Or you can schedule a meeting with us here

For more information about our award-winning clinical trials electronic data capture (EDC) platform, or to get in contact with a staff member, contact us today.

Hope to see you there!

Topics: Trade Shows, OCT2015

Education Partnership Highlights eCOS' Versatility

Posted by Greg Pack on May 12, 2015 3:06:00 PM

Spotlight: Education

Through our education partnership initiatives program, eClinicialOS collaborates with partners worldwide to bring innovative learning opportunities into Clinical Data Management. Sandbox_clippingOne of our education partners is Phoenix Progressive Certifications Enterprise (PPCE), based in Maharashtra, India. PPCE’s Certification in Clinical Data Management program has been running strong for the past 5 years and strives to increase employability and improve the quality of resources in the clinical research industry. 

eCOS supports the PPCE initiative - as well as many other education initiatives worldwide - by donating the use (and tech support) of our platform.

We recently spoke to PPCE  to discuss the new class that started in May 2015. 

 

Aditi Bose, Clinical Data Manager at PPCE is leading the charge to equip the young workforce in Maharashtra for a future in clinical trials. “Employable young people required by the clinical research industry cannot be easily found,” says Ms. Bose.  “As a result, companies are forced to hire people with lesser skill sets than actually required. Young, determined people looking for big opportunities do not have enough awareness of the growth in the clinical research industry to increase their career opportunities as well as their bargaining power.”

This is an area where eCOS and PPCE share the same goal. 

Every year PPCE holds multiple programs for Clinical Research and Clinical Data Management certification in conjunction with a well-renowned hospital, Ruby Hall, Pune, and college, St. Xavier’s, Mumbai. (Sidebar: In 2009, United States Secretary of State Hillary Rodham Clinton visited St Xavier's, and in November 2010 US President Barack Obama visited the college and held a town hall meeting.) 

In Mumbai, PPCE conducts CDM training at St. Xavier’s in their validated computer lab whereas in Pune students study onsite at PPCE’s fully functioning Clinical Data Management Training Lab. These students are then absorbed by companies such as Accenture, IBM, Cognizant, Tata Consultancy Services, InVentiv, Syntel, Gebbs Healthcare, Ruby Hall, Accord Therapeutics and others.

The eCOS platform in action 

 “We currently use the eCOS Sandbox, an open source EDC platform, for the CDM practicals,” says  Amit Kumar Yadav, (Business Development Manager). “We have found it to be an extremely user-friendly platform that takes our course a level higher.” Among the various features that students find useful are EDC, Medical Coding, and Electronic Patient Diaries.

“Developed to deliver maximum impact, our programs equip candidates with the knowledge and skill sets specifically required by recruiters,” says Mr. Yadav. “It has been our experience that the biggest mismatch in clinical research, and specifically in the Clinical Data Management industry today, is that young people are not aware of the possibilities in this growing area, and as a result, companies involved in managing clinical trials do not have the option to choose from a large pool of skilled resources. To do this, we run, at affordable costs, an array of programs and internships.”

And eCOS is extremely proud to be able to help. 

For more information on the PPCE education program, click here

For more insight, follow PPCE's LinkedIn page click here 

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Topics: Education

eCOS Receives PharmaVoice Top 30 Most Innovative Companies Award

Posted by Amy Young on May 8, 2015 4:26:00 PM

Listed among some of the largest and most forward-thinking companies in the world in the April 2015 Innovation issue of PharmaVoice magazine, eClinicalOS’s eClinicalOS division was named as one of the top 30 innovative companies in America.

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As eClinicalOS (eCOS) continues to change the way the industry views electronic data capture (EDC) in clinical trials management, the word is getting out.

In just one year’s time, eCOS has increased the number of trials active on our EDC platfom from 250 to over 500 trials!

This is a huge milestone and one we couldn't have acheived without our amazing customers, whom we consider to be innovators in their own right. 

How is our system different? Here are just a few highlights:
  • Rapid start-up time: Some studies have gone live within 10 days, which is unparalleled in the industry
  • Optional modules are all unified under our platform for ease of access, ease of use, and no hidden costs
  • Pay-as-you-go pricing means you only pay for what you use

For more about our system features click here.

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Topics: Awards

How I Became an eCOS Convert: One Data Manager’s True Story

Posted by James Kahl on May 8, 2015 10:30:00 AM

Like you, I used to run studies.  And in the days before EDC it could be really painful. 

When I was a Study Manager and a Data Manager for a large medical device company, we used carbon-based CRFs. We’d manage discrepancies by communicating through fax.  Randomizations would be through a batch of envelopes sent to the sites. Inevitably, they’d open the wrong envelope, get the wrong randomization assignment, and you’d scramble to correct things.  It was a mess, but that’s how things were run back in the day.

The industry has definitely evolved from those days. We eventually started using EDC systems, but they always underwhelmed me.  

Then I saw eClinicalOS (eCOS) and I fell in love. I knew right away that the system would make my life easier in so many ways. CDR-LIFE_PRESERVER

I know changing to or adopting new EDC systems can be tough. Believe me, I’ve been there. I saw lots of other systems before I discovered eCOS. (And I liked it so much I eventually went to work for the company! But I’d say all this even if I didn’t.)

Recently, I sat down to tell my story. The result is “12 Ways an EDC System Totally Changed My Life: One Data Manager’s Story.” Download it to read more about the specific ways eCOS can slash time, cost and risk from your next study.  And if you still don’t believe me, request a demo of the system and see it for yourself! 

Download eGuide Now!

Topics: EDC, edc adoption, data management

Bio IT World Conference Invades Boston

Posted by Greg Pack on Apr 29, 2015 2:00:00 PM
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April 24, 2015- Boston, MA

This year was our team’s first time exhibiting at the Bio IT World conference held in Boston MA. Well-attended by highly IT centric groups both exhibiting and attending, the hot topics ranged from advances in cloud-based platforms to speed and security of data.

Our own Don Turner, head of strategy and commercialization, and Eric Morrie, Associate Director of Wincere co-presented at a lunch session on the topic “Big Data in a Small World: Patient Centric Control in Global Clinical Trials.” The discussion centered around the idea of moving away from “population medicine,” where currently rising R&D costs have lead us to bypass small advances in medicine that may help a small subset of individuals, in favor of treating larger segments of the population. As both Morrie and Turner agree, the adoption of EHR and mHealth technology is paving the way toward a more personalized approach to medicine. Of course, this trend also brings several barriers and considerations for success.

Besides that, probably the biggest highlight for our team was impressing a member of the Saudi Arabian royal family in attendance with a demo of our platform. Well, at least his name tag said "King" on it (His translator confirmed it was indeed a royal).

Next up, eClincalOS will be attending DIA China in May and OCT Europe. Schedule a meeting with us today!

Topics: Trade Shows, IT, Big Data, BioITWorld

Efficiency, Cost Savings, Lip Balm All the Rage in Paris

Posted by Amy Young on Apr 24, 2015 1:00:00 PM

Last week, the Merge eClinical team attended the DIA Europe conference in Paris, France.  Over the course of three days, they mixed and mingled with life science leaders from all over Europe.  The team reported back four key findings:

  1. The weather was amazing, even for Paris in the Spring
  2. Our lip balm giveaway was insanely popular
  3. The macaroons were delicious, and
  4. Money and time savings still top the list of concerns for the clinical trial industry  

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On everyone’s lips (besides our lip balm) was Risk-Based Monitoring, a way to slash time and expense by targeting monitoring activities based on the highest level of risk in the study.  Reducing the time and effort spent on Source Data Verification makes a lot of sense when you consider that labor costs eat up a large chunk of your trial’s budget.

Take a quick look for yourself in this breakdown of average study costs, excerpted from our White Paper, “10 Proven Ways to Reduce the Cost of Clinical Trials:”

Efficiency_Cost_Savings_Lip_Balm_All_the_Rage_in_Paris

The practice of Risk-Based Monitoring is still evolving, but it’s clearly the way of the future when it comes to reducing some of your larger overhead costs.

And, as our team shared with show participants, another great way to save time (and therefore money), is by moving your data management to a cloud-based EDC (electronic data capture) platform. We may be a little biased, but we think ours is pretty great.  Schedule a meeting with us at one of our upcoming trade shows to find out more, or get a sandbox account and test drive the system for yourself. 

Topics: EDC, DIA, Risk-Based Monitoring, life science

Cloudy Lingo: 7 Terms Healthcare Professionals Need to Know

Posted by Greg Pack on Apr 23, 2015 4:00:00 PM

 In today’s world, vast amounts of information can be accessed on mobile devices, tablets and PCs at the touch of a fingertip. With privacy concerns at an all-time high, these tech advances have taken a bit of time to become accepted in the healthcare industry.

But all of that changed when the Centers for Medicare Services (CMS) released “Meaningful Use" incentives, and the US Government released the American Recovery and Reinvestment Act of 2009 (ARRA), two powerful changes to the traditional workflow in healthcare. These pieces of legislation encourage businesses in the healthcare industry to utilize certain applications and the connectivity of electronic health records.

So, we have come a long way, baby. In just 6 years, most medical management meetings in this country taking place right now are centered on value-based care and interoperability. And, cloud technologies have started to replace clunky legacy systems, offering easier, faster, and more cost-effective access to data.


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Are you new to "the cloud?" Here are 7 terms you need to know: 

SaaS 

A SaaS (Software as a Service) platform is an on-demand software delivery model. On-demand means that the software is never installed on a local machine — it’s always accessed over the Internet, or “the cloud.” “Apps,” or, applications, are run via a web browser. 

Public Cloud

In “public cloud” storage, enterprises and small businesses offload data and backup needs to a third-party cloud storage service provider, freeing them from the expensive costs of having to purchase, manage and maintain on-site storage hardware and software resources.


Private Cloud

While public cloud is external, “private cloud” is an inte

rnal storage cloud. Storage services are managed inside the data center and as a result almost always carry higher capital and maintenance costs than public cloud storage services.That's because they need to provide the data center space, network connectivity, power and cooling.

Hybrid Cloud

With hybrid cloud storage, businesses are able to mix and match cloud storage resources between local in-house data center infrastructure and scalable, on-demand off-site infrastructure. The off-site cloud provider typically fully manages the cloud storage.

The advantages of hybrid cloud are reliability, scalability, easy on-demand setup and potential cost savings of public cloud storage with the security and full control of private cloud storage.

EDC

An Electronic Data Capture system, or EDC, is a system created to report, upload, organize and store various clinical trial data from patients and trial sites their treatments and outcomes in electronic form as opposed to paper.

Cloud Envy

Used to describe vendors who jump on the cloud computing bandwagon by rebranding their existing services.

"Moving to Cloud"

When an organization is moving away from a traditional “Fixed Capital Asset Model” (buy the dedicated hardware and depreciate it over a period of time) to the operational expense (OPEX) model (use a shared cloud infrastructure and pay as you use it) they are referred to as "Moving to Cloud." 

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Topics: Data Exporting, Cloud, clinical trials, Apps, Saas, Switching Systems, Audit, Application, ePro, Encryption, Regulations, Investment, clinical research, Data Access, Switching EDC, Data Storage

eClinicalOS v2015.5.0

Posted by Sean Farres on Apr 22, 2015 2:00:00 PM

We are pleased to announce the release of eClinicalOS v2015.5.0 on Friday, May 1, 2015.  

eClinicalOS v2015.5.0 includes information on Data Exports as well as some other enhancements to existing tools.

V2-Exports_ByRevision

Here are a few highlights in the upcoming release:

Data Export Updates

Based on user requests, eClinicalOS v2015.5.0 includes several changes to the V2 Data Exports. The first change involves additional audit trail information for the subject status changes and updates the subject table, rand table, and adds a new table for historical subject status information. Other changes involve historical information for the Inventory/Dispensing module, including status and history of the batches, items, and shipments. All of these changes provide more information about your data and how it was collected.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, Data Exporting, EDC

WHO Calls for Quicker, More Transparent Trial Reporting

Posted by Amy Young on Apr 21, 2015 4:18:43 PM

Would it surprise you to learn that the methods and results of clinical trials are routinely withheld from the public?

According to the World Health Organization (WHO), it happens more frequently than you’d think. That’s why they’ve issued a public statement calling for the public disclosure of clinical trial results for medical products, regardless of the outcome. 

In the statement, WHO cites a study that analyzed reporting from large clinical trials on ClinicalTrials.gov. It found that 23% of studies with more than 500 participants completed by 2009 had no results reported, even 60 months past completion. microscope

The 2015 guidance, which expands on a similar 2005 position statement, recommends that summary results be posted on a registry and submitted to a peer reviewed, open access journal within 12 months of completion.  (They do allow for a grace period, noting that results should be made public “at most within 24 months of study completion.”) In addition, they ask that past unreported trials be disclosed in a registry and published if possible.

WHO: Unreported trials lead to misinformation

Why is underreporting of trial results a problem? Well, patient safety, for one. Withheld results prevent informed healthcare decision-making and could produce disastrous outcomes - not to mention an erosion of the public’s trust. Eventually, it could make it harder for sites to recruit willing volunteers for their studies.

The industry widely cites publication bias (publishing only those results which are likely to be read) as one of the biggest reasons for this lack of transparency. The WHO’s guidance is a step in the right direction, but as some have pointed out, we have a ways to go in getting 100% of trial results reported. 

Better data = easier reporting

At Merge eClinical, we think that one way to ensure better result reporting is by having better, easier-to-access data. A great EDC can make that possible.  Consider the fact that your trial is likely to capture millions (or more) of data points. Our cloud-based platform can help streamline and simplify the management of all that information. Read more about our robust reporting capabilities here and here. Or, if you’d like to see our system in action, simply sign up for a sandbox account and give it a test drive.

Topics: clinical trials, reporting, World Health Organization

New FDA Guidance Could Help Cut Trial Timelines

Posted by Amy Young on Apr 16, 2015 2:00:00 PM

Some rules and regulations seem like they were designed to make our lives harder. But recent guidance from the FDA aims to simplify and streamline the clinical trial process in one key area: Informed Consent.

As everyone in the industry knows, consent forms are an essential part of conducting research. Without them, patients would enter blindly into treatment without knowing and understanding the full risks and benefits. (Not to mention, it’s the law.) 

FDA

For years, clinicians and researchers have interpreted this requirement as a mandate to obtain the patient’s manual signature on a form. But what happens to that piece of paper after it’s signed? Most likely, it sits in a folder, collecting dust.  It’s at risk of getting lost or stolen. If you had to provide legal evidence that a patient did indeed sign the consent form, would it always be easy to find?

It would if it was in digital form.

That’s part of the reason the FDA now says it’s ok to use graphics, audio and visual aids, podcasts, interactive websites, card readers and even "biological recognition devices" to deliver and capture information related to the informed consent process.

It’s not just about the signature 

Document retention benefits aside, interactive digital technologies could actually enhance the quality of the consent process, helping patients make better, more informed decisions. And, most significantly, it could cut time from the process by allowing consent to be obtained from the patient’s home or another remote location. Just think of the time you could save by eliminating an extra clinic visit!

Of course, as the old adage goes, consent is more than a signature: It’s a process. You need to make absolutely sure that patients understand what they’re getting into – and that all their questions have been answered, no matter where the consent is obtained. The FDA addresses this in their guidance, requiring that you allow the patient to "ask questions and receive answers prior to signing the electronic informed consent document to participate in the study.” Nowadays, there are myriad interactive digital technologies available to make this part of the requirement simple to accomplish. 

Finally, don’t forget to bake in Information security and privacy to the process.  Data captured in the course of obtaining electronic informed consent must not be able to be altered, and the patient's privacy should be carefully safeguarded. Language addressing security and privacy is also included in the FDA guidance

Three cheers for digitalization!

It’s no surprise that we at Merge eClinicalOS are big fans of digital transformation. On a larger scale, we’ve seen firsthand the power of moving your trial’s data management from paper to the cloud. (Hint: It can save you a whole lot of time and money.) In fact, did you know that EDC adoption is also FDA-approved?

We’re thrilled to see the FDA acting to help move technology and innovation forward. You can read more about their efforts to modernize the industry here.


 Are you heading to Bio IT World Conference and Expo in Boston next week? Stop by booth #119 and visit the Merge eClinical team! 

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Topics: clinical research, FDA, Informed Consent

What Does Google Fiber Mean for Clinical Research?

Posted by Greg Pack on Apr 13, 2015 9:41:29 AM

On January 24th, 2015, whoops of celebration could be heard in cities across the southeast – including Merge eClinical’s hometown of Raleigh, NC.

Dollarphotoclub_70432628-EDITEDWhy the hoopla?  Two words: Google Fiber.

No, it isn’t some sort of nutritional supplement. It’s a new technology that’s going to make your internet really, really, REALLY fast – and it’s gradually being implemented in cities across the U.S. 

Google Fiber transmits data using light pulses through glass tubing or optical fiber buried in the ground, allowing data to be transferred at speeds of 1 gigabit per second (Gbps). A gigabit network is 100 times faster than the highest-speed internet available. To put this into perspective, you can download a full-length album in 6 seconds. The entire Harry Potter movie series in less time than it takes to microwave some popcorn. It’s as close to instant gratification as you can get.

 “There’s just NO comparison. What used to take days - or even longer - can now be done in hours or less,” says big data geneticist Reid J. Robison MD MBA. He claims that with fiber, he is able to download an entire human genome in a little over 3 hours, a task that takes an average of 77 hours on an ordinary internet connection.  

eClinicalOS and Google Fiber

Merge eClinicalOS is a SaaS (software as a service) platform used to capture data for managing clinical trials. Information is entered at trial sites and uploaded to a cloud server, where it is stored for analysis and an audit trail. Having Google Fiber under the hood is a very big deal for a web-based EDC (electronic data capture) product. In short, it means that data can be delivered much, much faster.

 SaaS EDC systems are moving to capture bigger and bigger data. Faster internet means downloads and uploads are quicker. This affects monitoring reports, images for clinical trials, imports, and SFTP transfers. As metadata is used more in clinical research, EDC companies will have to be able to download, utilize, and regurgitate metadata into larger data sets.

 And, as the world’s bandwidth increases, web pages will grow and change. Web designers will have more capabilities and options that will affect usability, connectivity and functionality improvements, particularly in the booming SaaS market.

 The bottom line? Google Fiber can significantly accelerate data capture, data analysis, and reporting in clinical research. And in this industry, efficiency is everything.

What’s next?

 Google Fiber is currently available in 3 U.S. cities, with 5 additional cities to be added soon – and more in the works.

 Dennis Kish, Vice President at Google Fiber says, “Our next step is to work with cities to create a detailed map of where we can put our thousands of miles of fiber, using existing infrastructure such as utility poles and underground conduit, and making sure to avoid things like gas and water lines. Then a team of surveyors and engineers will hit the streets to fill in missing details. Once we’re done designing the network (which we expect to wrap up in a few months), we’ll start construction.”

For more information on Google Fiber, where it’s going, and what’s happening, keep up with the Google Fiber blog.


 

Are you heading to 27th Annual DIA EuroMeeting in Paris this week? Stop by booth 3.D16 and visit the Merge eClinical team! 

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Topics: Google, google fiber, clinical research

eClinicalOS v2015.4.0

Posted by Sean Farres on Apr 7, 2015 1:00:00 PM

We are pleased to announce the release of Merge eClinicalOS v2015.4.0 on Wednesday, April 15, 2015.  

Merge eClinicalOS v2015.4.0 includes information on the Resupply Enhancements as well as some other enhancements to existing tools.release_vids_thumb

Don't forget, we have Product Release Videos for the last several eClinicalOS updates including v2015.4.0. Please contact us directly if you are interested in viewing our current collection of release videos!

Here are a few highlights in the upcoming release:

Resupply Enhancements

In response to client requests, we are upgrading the Site Settings to include a "Resupply When" and a "Combined Floor" option. The "Resupply When" defaults to 'Any type is needed', indicating that when the value of any type of inventory falls below the Floor value, all types are resupplied in the shipment. However, you can also choose to resupply only when 'This type is needed' or resupply with a combined floor value. The "Combined Floor" allows you to resupply two or more types when combined inventory falls below a single floor value. The selected types are then resupplied as a group to their respective Ceiling counts.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, EDC, resupply enhancements

Early Phase Successes: Are We On the Cusp of Something Huge?

Posted by Amy Young on Apr 2, 2015 4:18:50 PM

Phase I clinical studies are small, early trials featuring just a handful of patients. They’re mainly conducted to determine the right dosage range and evaluate safety for a newly discovered treatment. Their goal is not to establish clinical effect. That’s why they don’t usually make headline news. But recently, results of some Phase I trials have done just that – and the excitement is building.  



Killing Cancer

The one you’ve probably heard about was featured on the CBS news show “60 Minutes.” On the March 29 broadcast, anchor Scott Pelley reported on the groundbreaking results of a Duke University Phase I clinical trial. In it, researchers used the polio virus to treat glioblastoma, one of the deadliest forms of brain cancer. A mere 22 patients have participated in the trial so far, but for some of them, the treatment eliminated their cancer entirely. Yes, you read that right. Cancer. Cured. Those are two words many of us never thought we’d hear in our lifetime. It’s even bigger news when you consider that most people with this form of cancer are given survival prognoses in months, not years.

Advancing Alzheimer’s Treatment

There’s also great news in the world of Alzheimer’s disease. Pharma giant Biogen recently released Phase I data that indicates promising results for their drug, known as BIIB037 or aducanumab. The 166 patients in the trial showed a statistically significant improvement in cognitive function and a decrease in brain plaque. What’s even more impressive is that this is the first investigational new drug for this indication to show such results. While there are safety concerns and other worries (especially given the failure of similar therapies in the past), millions of patients and families suffering from this devastating disease now have new hope.

Ratcheting up the pressure

It’s tempting to get worked up about these successes and their world-changing potential, but some caution is warranted here. Science isn’t always as precise as we’d like, and what worked for a few early patients could fail for the next. Fact is, only five in 5,000, or 10% of treatments, make it to approval for human use. 

It remains to be seen whether Phase II and III will demonstrate large-scale clinical effect for these therapies. There are certainly huge potential roadblocks along the way. Big phase III trials can take years and cost millions – sometimes billions. Researchers, developers, and investigators are under pressure to move quickly, with unprecedented efficiency, accuracy, and quality.

The risks are huge, sure. But so are the rewards. Just ask the two patients in the Duke trial now in remission who didn’t think they’d live to celebrate their next birthday. 

Topics: Industry Insights, clinical trials, phase I

B-Ball, BBQ, and Biotech

Posted by Greg Pack on Apr 1, 2015 3:00:00 PM

PSD-OCT_SOUTHEAST_ROTATOR_IMAGE
Here in Raleigh-Durham, North Carolina, we’re rabid about our college basketball teams. We love some good BBQ. And we’ve got one of the most prominent high-tech research and development centers in the United States - Research Triangle Park - just down the road. At Merge eClinical, we’re lucky to call this place home. So you can imagine our excitement when we found out that the Outsourcing Clinical Trials (OCT) Southeast conference would once again be hosted right here in our backyard.

No doubt about it, there’s a huge volume of life science talent in our community, and OCT brought them out in droves. On March 24 & 25, our team enjoyed some great conversations with biotech and small pharma companies on ways we can help each other succeed.  

During the conference, Chad Papineau (@ChadPapineau8), our Senior Director of Business Development, delivered a well-received presentation titled “Continuous Quality Improvement Through EDC”. After walking through an overview of the current clinical trial landscape, he delved into some exciting new technologies that have the potential to get needed therapies to market much sooner­.

Some of the most profound scientific discoveries of the past century have been influenced by scientists and researchers working in RTP. We can’t wait to see what the future holds!

Topics: EDC, OCTSoutheast, OCT2015, Outsourcing in Clinical Trials

Are You A Micromanager?

Posted by Amy Young on Mar 30, 2015 11:11:19 AM

The Top Line:

  • The tell-tale signs of micromanagement
  • How the Cloud can help inhibit micromanagement
  • Micromanagement is ironically rooted in – and can be cured by – success

Are you swamped with work because you find it hard to delegate? Do you constantly feel the need to “check up” on what your employees are doing? Are you a bottleneck because everyone is always waiting for you to approve everything?

If the answer to any of these questions is yes, it’s time to face the truth: You might well be a micromanager (cue: scary music).

While perhaps well intentioned, micromanagers think they’re getting the job done by making certain that everyone else is getting their jobs done which, coincidentally, is the best way they know how.

Okay, stop for a second.

Re-read those last three words, because therein lies the problem.

Micromanagement occurs when a business owner or manager stifles employee productivity and self-sufficiency by exercising excessive control over the work process. They delegate work, but feel compelled to involve themselves with every single detail of the task, including how it gets done. The results all too often are needless delays, frustration and toxic resentment throughout your team.

Micromanagers often don’t – or can’t – recognize their hovering, judgmental and authoritarian management style as controlling and counter-productive. Instead of encouraging autonomy, they unconsciously erect behavioral “Jersey barriers” to productivity based, ironically, on their own personal success.

As the Harvard Business Journal reported recently, moving up the managerial food chain can create the “emerging micromanager.” Such an individual paradoxically may feel disconnected from the organization’s actual work, which can fuel the need to seek information (and, therefore, feelings of safety and control) in as many ways possible. The manager may also experience trouble letting go of his or her old job because it is linked with the success that led to the promotion.

Red Flags

If your employer or team members (especially!) think you are a micromanager, you not only are jeopardizing your effectiveness as a team leader, but also the quality of the work product for which you are ultimately responsible.

To help you make the right diagnosis, here is a list of clues that suggest you may toeing the micromanagement line:

  • You assign work but then take it back because as it’s not being done the way you would do it.
  • You dictate precisely how you things must be done and leave no room for individual initiative.
  • You regularly push out project deadlines because you are hung up on the details.
  • You are hesitant to invite your team members to contribute new ideas, communicate with clients or even talk with one another about specific tasks.
  • Your team’s turnover is abnormally high.
  • You question the processes followed, work completed and proposed next steps at every status meeting.
  • You schedule meetings to discuss upcoming meetings.
  • You default to focusing on tactics, rather than working on strategy.
  • You habitually work nights and weekends and believe anyone who doesn’t behave similarly just isn’t committed to the job.

And finally…

  • You believe that if you want something done right, you have to do it yourself.

Micromanagement and the Cloud

Most life science professionals recognize that, when used smartly, information technology advances such as Cloud-based solutions enhance productivity, cost-efficiency and autonomy. In the eyes of a micromanager, however, the Cloud and its ability to drive greater worker independence is both scary and dangerous and represents all that is wrong with IT.

As businesses shift tasks and resources to the Cloud, those who fear losing control over assets that were once under their tight control can cause problems. For example, micromanagers may implement backward-looking policies that satisfy their need for control, but ultimately hamper productivity, waste company resources, alienate employees and risk company/client relationships.

Let’s look at an example. Say Company A decides to adopt a Cloud-based EDC platform to improve their ability to manage complex, multi-site trials. When embraced, the software’s data collection, sharing and reporting capabilities allow greater autonomy for researchers that, in turn, helps increase employee productivity and morale while decreasing overall study costs.

Improving study efficiency while lowering costs would seem to be a no-brainer, right?

Not to a (cue: scary music again) micromanager.

Because of the perceived lack of control, micromanagers might miss the point that employees are using this file- and document-sharing service to be more effective and productive. In response, a micromanager might insist that every aspect of the data review and reporting process must go through him or her to “ensure accuracy.” And that, of course, stymies the very benefits the EDC platform can deliver: speed, efficiency and accuracy.

Short of shock therapy, how does the physician “heal thyself”?

Moving From Micro to Macro

Micromanager may be creatures of bad habits, but the environment in which you work certainly can play a role. Moving away from the urge to control toward the ability to manage (or better yet, lead) takes a combination of the right skills, the right communications and the right culture.

1. Make smart hires.

Hiring the right people who themselves are accountable and confident in their abilities helps build and reinforce an accountable culture in your area and at your organization. Responsible, dependable and dedicated employees engender trust, which lets you manage the workflow, rather than closely supervise (read: hover over) them.

2. Communicate clearly and consistently

Second, when employees are unsure of what is expected, it can be difficult to correct counter-productive behavior and leave the micromanagement impulse behind. Weak communication up and down the chain fuels the growth of micromanagers, and the only effective antidote is good communication. That is to say, you must communicate clear expectations to your team that help you collaboratively set goals and evaluate progress (good or bad) toward them. The responsibility for encouraging constructive communication throughout the organization starts at the top.

3. Cultivate a culture of trust

Third, at the risk of introducing an earworm of truly enormous proportions, if you want to lessen the power that the micromanager devil inside you has, you have to “Let It Go.” Always strive for excellence, but let go of perfection, especially when delegating to others. Expecting perfection that matches precisely how and when you would do something is crazy-making behavior (for you and your team).

Give team members the leeway to complete a task their way, and welcome ideas that could improve the process and outcome. Greater performance latitude is similar to solving a complex math problem or traveling to another city: there are multiple roads one can take to arrive at a desired destination, and no one – and that includes you – always has the right answer. Focus more on the destination and less on the methods used to get there.

And when expecting the right answer, let your team bring it to you. Asking fewer questions builds the expectation of your team taking the initiative to do the reporting (a good thing), instead of you having to do the chasing (which is not a good thing).

Consistently reaping top performance from employees is not easy, but the right combination of tools, talent and smart management can help make it easier to reach that goal more often. And best of all, you can reach that goal without believing you have to do everyone else’s job as well.


Did you find this information helpful?

You might also be interested in reading one of our FREE eGuides, "The Productive You: 18 Essential Apps That Will Change Your Life."

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Topics: Industry Insights, Cloud, EDC, clinical trials, micromanager, Saas

CRO Business Development Essentials in a Consolidating Market

Posted by Amy Young on Mar 25, 2015 2:12:55 PM

The Top Line:

  • Smaller CROs will typically attract similar-sized biopharma companies
  • Know your target, know yourself
  • Keep satisfied clients close

railroad

With the globalization and consolidation of the clinical trials industry marching on, what’s always been a big question now looms even larger: how can smaller and medium-sized CROs grow and thrive? 

While mega CROs are inking strategic partnership deals with Big Pharma, there is still maneuverability in the market for medium and smaller firms to help like-sized pharma, biotech and device counterparts move their molecules and products forward.

If your goal is to grow as an independent company (or get bigger and be acquired), filling the pipeline and building value for your CRO now take on even greater importance.

Fortunately, three simple reminders can help you stand tall against the competition in a world increasingly ruled by giants: Know who you are, know the types of business you can serve, and know where and how you can seed repeat business.

Who are you?

(Wait. If we just inadvertently stuck an earworm in your head, don’t blame us, blame The Who…)

Okay, now back to business.

Let’s start with the key business development question: what is the most important sales activity you will use to drive growth in the next quarter? A fractured answer indicates you need to cancel out all excess noise and focus on the single task that is likely to yield the best results.

An effective exercise to marshal your resources is to map the client journey. Understanding current pre-sale to post-sale activities can help you refine client targets, which then can provide ideas on how to trim costs and boost client satisfaction. From there, you can look how your refined process combines with your marketing and target your ideal client with more precision. Then execute. Relentlessly.

When planning, don’t exclude anyone on your team. In smaller CROs, employees may have less rigidly defined roles and more responsibilities, and you can and should take advantage of that diverse knowledge and experience (especially from client-facing professionals in your organization). When all are on the same page (i.e., everyone understands the direct impact he or she has on client service and sales), business development becomes part and parcel of your company’s DNA and yields positive results more regularly. 

The Satisfied Smaller Client

At first, smaller to medium-sized CROs may seem to be at a distinct disadvantage in an era of the global CRO, but David still has some punch he can deliver to Goliath. (Or even better, he can aim his sling in a different direction.) Truth is, there are enough emerging pharmas, biotechs and device companies around to keep smaller shops humming for years to come. The key is to identify such companies and put yourself in front of them.

Now more than ever, sponsors that aren’t among the industry behemoths worry about being overlooked by the top CROs and their general appetite for serving large pharma (and the accompanying large budgets). Small, stable and privately held companies become attractive precisely because of those traits and because of the competitive advantages they offer in reducing overall study costs.

With so much competitive information available on the Web, reputations today are won and lost by how companies deal with clients. The most successful relationships between customers and service providers are built on transparency, authenticity and working in open and honest partnership with one another. Smaller companies can provide personalized attention and demonstrate shared commitment in ways that win client confidence and trust.

Free from the burden of bureaucracy that often hamstrings big organizations, small and medium-sized CROs offer advantages that are especially attractive in the clinical research world of 2015: agility, flexibility and adaptability. And by leveraging cost-effective, scalable data management platforms and other tools now readily available in the Cloud, they can manage virtually any trial anywhere in the world with ease.

Internal Cross Selling

One of the most overlooked business development tools, cross selling is very often talked about but rarely executed well. Of course, marketing to potential clients is necessary to help generate new leads, but it is much easier – and less costly – to generate new business from existing clients.

And here is where the client’s experience with you and the results you’ve delivered pay dividends. You already have the client’s attention to communicate your full range of services that either they may not know about or you have recently developed. Once a successful engagement is complete, that’s the time to ask questions about how you can help further and follow up on your client’s additional needs.

And paying attention to the personal side of business is critical. Remember the core principle of building effective relationships: Never treat others as you would not want to be treated yourself.

The Bottom Line

Consolidation in the industry no doubt will continue, but with foresight and focus, smaller CROs can attract and retain profitable clients. Bottom line – get growing by: (1) aiming for the right sized clients; (2) anticipating and exceeding clients’ expectations; and (3) directing all of your team’s efforts toward client satisfaction. Size doesn’t matter when it comes to customer service.

You may not be the biggest CRO in town, but there’s nothing that says you can’t be the best.


Did you find this information helpful?

You might also be interested in reading one of our FREE eGuides, "10 Proven Ways to Reduce the Cost of Your Clinical Trial."

Download eGuide Now!

 

Topics: Industry Insights, CRO

eClinicalOS v2015.3.0

Posted by Sean Farres on Mar 18, 2015 2:00:00 PM

We are pleased to announce the release of Merge eClinicalOS v2015.3.0 on Friday, March 27, 2015.  

Merge eClinicalOS v2015.3.0 includes information on the new Data Tracker Report as well as some other enhancements to existing tools.release_vids_thumb

As a reminder, we've also created Product Release Videos for the last several eClinicalOS updates (2015.2.0, 2015.1.0 and previous releases from 2014). These videos will be made available from within the eCOS platform upon the release of v2015.3.0. In the meantime, please contact us directly if you are interested in viewing our current collection of release videos!

Here are a few highlights in the upcoming release:

New Data Tracker Report

We have heard your feedback on the Data Listing/Grid and are releasing a new generation – the Data Tracker. As a new report, the Data Tracker will make use of the new formatting, including search, pagination, and the multiple filter options. You can include CRF data, subject information, site information, and randomization or EAM data. The report also handles the repeating elements more efficiently.

Deleted Data in Exports

Traditionally, we captured limited deleted information in data exports – standard tables simply captured whether the subject, page, query, or EAM event was marked deleted. Several clients expressed a need to archive all data captured in the EDC, even if it was later deleted. To help with this, a new attribute has been added to V2 Data Exports (all formats). This attribute allows you to generate the traditional export, an export with just deleted or a combination of the traditional with deleted data included. .

Expanded Navigation in EDC

Previously, you could move from one subject to another on the Subject View or CRF page by clicking the Next/Previous arrows in the grey Subject View bar. With eClinicalOS v2015.3.0, we include a search box between the two arrows, so you can jump to another subject rather than just the next or previous.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@eclinicalos.com

Login to eCOS

 

Topics: Release Notes, Data Exporting, Reports, EDC, release videos

Meet Us at OCT Southeast 2015

Posted by Dianne Chatterton on Mar 17, 2015 3:00:00 PM

OCT2015-1

On March 24-25, 2015, the Outsourcing Clinical Trials (OCT) Southeast event in Cary, NC will bring together leading senior-level industry representatives and investors to provide an ideal platform to engage in potential clinical outsourcing/partnerships for biotech and small pharma companies within the Southeast region.

In addition to eClinicalOS (@goecos) being a session sponsor at this year’s conference, our President, Zaher El-Assi (@zelassi), will be speaking on supporting continuous improvement through extending the benefits of EDC on Wed, March 25 at 11:30.

Included in the discussion will be:

• Investigating EDC use as encouraged by the FDA for the significant benefits to everyone involved in a clinical trial, including sponsors, investigators, and patients

• Utilizing EDC to help clinical studies run more smoothly, and cloud-based EDC systems that provide even more benefits

• Evaluating cloud-based software to allow for the storage of protocols, assignments, and patient data, in one central location for all sites in a clinical trial

• Implementing cloud-based EDC systems for more complex clinical trials studies to ensure data monitoring and reporting are more efficient


We hope to see you there!

Click to Request a Meeting

Topics: EDC, clinical trials, Clinical outsourcing, Pharma, Biotech

ACDM Clinical Data Management Webinar Series

Posted by Dianne Chatterton on Mar 13, 2015 4:04:11 PM


ACDM Webinar Image

Continuing Professional Development (CPD) is a way for professionals to demonstrate that they continue to learn and develop throughout their careers, to keep their skills and knowledge up to date and are able to work competently. We at Merge eClincalOS believe strongly in CPD, and host hundreds of webinars every year featuring the latest industry trends and tips to enhance the individual skills, knowledge and professional development of its users. In this blog we will explore the upcoming Level 2 Accredited Training Program Webinar Series, “Clinical Trial Management- Technical Skills,” being run by our featured European educational partner, the Association for Clinical Data Management (ACDM).

Who is ACDM, and why should you attend the training program?

Based in UK, the ACDM (twitter: @acdmDatamatters) was founded in 1987 and has been putting out fantastic educational resources to its members for many years. The core objective of the ACDM is to equip users to participate more effectively in the mainstream of drug development.

This course does just that.

Extended over 6 sessions from April through to June 2015 and comprised of 5, 75 minute Webinars and 1 Face-To-Face session, delegates will be expected to successfully complete pre and post-course work in order to complete the accredited program. Comprehensive course materials are provided and practical exercises will include hands-on activities with our “Sandbox” version of our very own Electronic Data Capture (EDC) system, Merge eClinical OS.

Regulators are increasingly requesting evidence of competence. Experience alone does not provide evidence of competence. The ACDM, in partnership with the International Academy of Clinical Research, has developed this series of training programs supported by comprehensive course work and interactive sessions, providing independently recognized, competence-based accreditation to support the continued professional development of staff involved in the management of clinical trial data.

CPD points are related to the notional learning hours in taking a course and include any learning hours spent on pre-course work and any post-course work. The latter includes collecting the learning evidence on the job and taking part in the assessment process.

Each of the ACDM’s courses has been assigned a number of CPD points based on the time involved in participating in the course and in completing assigned pre- and post-course work.

The courses are quality assured by bodies regulated by Ofqual (Office for Qualifications and Examinations Regulation) and the levels are recognized within the ISCED framework (International Standard of Education) framework produced by UNESCO (United Nations Educational, Scientific and Cultural Organization).

The Level Two Accredited Training Program in Clinical Data Management is aimed at further developing essential technical and applied clinical data management skills. The training courses are highly interactive and supported by comprehensive materials and evaluated course work.

Course Learning Objectives

Understand how to lead the technical data management activities on a clinical trial.      

  • Explain the data management tasks to be performed from study set-up to close out. 
  • Explain key considerations for data collection from various sources including clinical trial assessment visits, patient reported outcomes, electrocardiograph, laboratory data and imaging. 
  • Describe mechanisms used to allocate tasks to the roles of the data management team. 
  • Explain how to ensure data quality from the Case Report Form (CRF) design go-live to database lock.

Understand the reasons for transparency in clinical trial data management.             

  • Describe the reasons for data transparency in clinical trial data management.
  • Compare and contrast the use of paper and electronic audit trails.
  • Explain access control to clinical trial information.

Understand how to integrate clinical study data with other important sources of clinical trial information in accordance with the International Conference on Harmonisation Good Clinical Practice (ICHGCP) principles.    

  • Describe other eClinical tools (ePRO/clinical trial management systems/randomisation tools).
  • Explain how information from these systems is useful for clinical data management.
  • Evaluate strategies for managing version control challenges when working with classification systems such as the Medical Dictionary for Regulatory Activities (MedDRA).
  • Analyse the importance of computer system validation and the processes involved.

Schedule

  • Webinar 1 -  10th April 2015 (12:00 GMT / 75 mins)                      
  • Webinar 2 - 24th April 2015 (12:00 GMT / 75 mins)                        
  • Webinar 3 - 1st May 2015 (12:00 GMT / 75 mins)                
  • Webinar 4 - 22nd May 2015(12:00 GMT / 75 mins)               
  • Webinar 5 - 5th June 2015 (12:00 GMT / 75 mins)               
  • Face-To-Face Training Session day - 15th June 2015 (venue TBC)

  Register for Webinar Series Here

 

Topics: CRO Partnerships, Resources, Webinar

The Productive You: 18 Essential Apps That Will Change Your Life

Posted by Amy Young on Mar 11, 2015 3:00:00 PM

 

three steps in choosing next edc

The objective of work is to get things done. Simple, right?

But perpetual phone calls, endless emails and mind-numbing meetings (not to mention hundreds of other daily distractions) can quickly complicate matters and sap productivity. Which leads to more stress and frustration. Which, in turn, leads to lower productivity.

Feeling a strange sense of déjà vu all over again?

If there’s one thing we prize at eClinicalOS, it’s efficiency. After all, we built our company around the concept of helping clinical researchers work smarter through advanced information technology. So it’s only natural that we relentlessly search for ways to be more efficient ourselves. And when we discover them, we’re eager to share them.

We've developed an eGuide especially for individuals who work in clinical research. In it, we profile and provide links to 18 of the best apps we've found that can help you get and stay more organized, more efficient and more productive in your day-to-day work. Some may be old favorites, but we're betting a number of them will be new to you (though we're sure they'll soon become old favorites, too).

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Did you find this information helpful?

You might also be interested in reading one of our FREE eGuides, "10 Proven Ways to Reduce the Cost of Your Clinical Trial."

Download eGuide Now!

 

Topics: Industry Insights, Apps, eguide, Information Technology, productivity

10 Proven Ways to Reduce the Cost of Your Trial

Posted by Amy Young on Mar 11, 2015 9:00:00 AM

The Top Line:

  • Cost reduction measures can be implemented in different phases of a clinical trial and may be direct or indirect in nature.
  • EDC and eClinical platforms offer multiple opportunities to reduce costs and increase efficiency.
  • Thoughtful negotiation and understanding of contract models is essential to avoiding budget overruns.

three steps in choosing next edc

Trimming study budgets is a good thing, right? Well, yes and no. When you can cut costs without compromising data integrity or accuracy, that's usually a good thing. But when cost cutting is only about saving money no matter what, it can increase frustration, impair quality, damage reputations and end up increasing project costs in the long run.

In short, there are no “blue-light specials” in clinical research. There are, however, a number of evidence-based strategies you can use to streamline your research and trim budgets that maintain – and, in many cases, enhance – data quality, staff productivity and employee satisfaction

To learn more about the 10 most powerful strategies to help maximize cost reductions in your trials, please download our free eGuide.

Download eGuide Now!

 


Did you find this information helpful?

You might also be interested in reading one of our FREE eGuides, "The Productive You: 18 Apps That Will Change Your Life ."

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Topics: Industry Insights, cost savings, clinical trials, eguide

Three Steps In Choosing Your Next EDC Solution

Posted by Amy Young on Mar 10, 2015 1:59:13 PM

The Top Line:

  • Reach out to the industry to learn about available systems.
  • System pricing runs the range, as do productivity savings.
  • Full-featured product demonstrations let you drive before you buy.

three steps in choosing next edc

When it comes to selecting an EDC provider, your choice will depend on a range of factors and needs. Usage requirements to efficiently perform the functions and tasks required for successful project delivery, and your budget, will be prominent decision points. But where to start? 

Even with the plug-and-play operability of SaaS systems, three steps can guide your assessment and help shorten the time between thinking about system vendor options and executing your first study

Research it

Like practically everyone else researching a product or service, the first place you’ll turn to for insight about EDC providers and systems will be the web. But simple queries are just the beginning. To support your search, look at objective webinars; see what companies are attending trade shows, and peruse annual buyer’s guides.

For other people’s knowledge, impressions and experiences, LinkedIn Groups is a ready resource that can help you locate EDC specific content and insight. Three highly active groups where you can ask members about EDC and clinical research are Clinical Research Professionals, Association of Clinical Research Professionals and Electronic Data Capture.

In addition to your research, it’s often helpful to ask colleagues both in and out of your organization what systems and companies they’re familiar with.

Price it

Bare bones technology or bells and whistles functionality? EDC systems run the range.

CROs, sites, sponsors and AROs are similar in that they conduct studies, but the size and kinds of studies they run, depending upon markets and therapeutic areas, will be different. When considering EDC systems, be sure to look at your end-user requirements and scrutinize the high-level system necessities you must have.

When determining your budget, keep in mind the pay-as-you-go option. You’re looking to cut costs, but this doesn’t mean choosing the cheapest EDC system on the market. Transitioning data to the new system, data security and expected savings over time between the old and new systems are factors. Ultimately determining the EDC budget should be based on a cost-benefit analysis of the system’s functionalities versus the study’s needs.

Another potential cost-saving consideration is IT. Business in general is becoming more reliant on the cloud and less dependent on traditional IT hardware and software installation and maintenance. Cloud-based EDC offers greater automation of IT activities with simplified updates and upgrades. But something else is also becoming simpler: IT department involvement.

With a reduction in maintenance and monitoring, participation by IT is diminishing and changing. As ECD evolves, IT professionals will have diminishing contribution in building study designs, allowing the clinical professionals to function more independently, and, as a boost to productivity, reducing personal and their associated time involved with studies. It also reduces vendor involvement. Users will be less dependent on help lines, which for some EDC vendors, is a lucrative profit center.

Demo it

Words on a website are one thing. Playing under the hood is another. After comparing systems, take the ones you’re considering for a test run. System sandboxes are where you can experience a system first hand and get a feel what it’s like to live with it every day.

The demo should offer the full user experience as if you were running an actual study. Must-have features in today’s indispensable EDC feature set include data entry, coding and randomization features, project management tools, customized reporting features, reusable templates and forms, compatibility with GCP guidelines (and all applicable regulatory guidelines, of course) and the ability to handle data from multiple sites across the globe.

Every capability and service should be represented, not a stripped-down version. The extent that you test should be up to you. And always look for strings that should never be attached.


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Topics: Industry Insights, EDC, edc adoption

Turn It Around: Three Proven Ways to Get a Handle on Staff Turnover

Posted by Amy Young on Mar 9, 2015 9:00:00 AM

The Top Line:

  • Employee turnover, especially in the healthcare sector, is projected to increase in the next decade.
  • High churn rates mean increased recruiting and training costs, client dissatisfaction and loss of productivity.
  • Focusing on communication, commitment and choice can help you reduce turnover.

exit

Employee turnover affects all organizations regardless of size, sector or location. It can hurt your organization in a range of obvious and not-so-obvious ways, including increased hiring/training costs, dissatisfied clients, quality breakdowns and decreased competitiveness.

And the situation is not likely to get better anytime soon. According to a study from global management consultant firm The Hay Group and the Centre for Economics and Business Research, employee turnover is going to become a much more serious problem in the future:

Workers around the world are already starting to seek new job opportunities as growth returns and labor markets begin to pick up. In 2018, 49 million more employees will be heading out the door compared to 2012 – a total of 192 million employees worldwide. The global employee turnover rate will see the sharpest increase in 2015, with the greatest growth happening in that year.

Continuing reverberations from the Great Recession and seismic populations shifts are combining to make employee longevity a rarity in the workplace. Expectations of a “job for life” have gone the way of the phone booth and 40-hour workweek. Harsh cutbacks in the wake of healthcare reform and the 2008 meltdown have left a generation of workers without loyalty to any employer.

Further, in just over a decade the Millennial Generation (i.e., workers who reached adulthood around 2000) will comprise roughly three-quarters of the global workforce. With radically different life experiences and expectations of work from those of their older colleagues, Millennials are projected to have significantly higher turnover rates. According to the U.S. Bureau of Labor Statistics from 2012, median employee tenure for workers aged 25 through 34 is just 3.2 years, nearly 50 percent less than that for all employees.

Higher Turnover Rate Costs Clinical Research Companies

While a rewarding career, clinical research often can be a frustrating, stressful and demanding environment. Peter Mansell in a Pharma Times Digital article reports that employees at contract research organizations are leaving for new jobs at a far higher rate than their counterparts in other industries. Employee burnout plus the “grass-is-always-greener” syndrome leave many companies in a near-constant cycle of recruiting and training.

And when you factor in all of the costs associated with employee turnover (e.g., interviewing, hiring, training, reduced productivity, etc.), it is far more expensive to replace rather than retain an employee. According to Karlyn Borysenko writing in ZenWorkplace.com:

  • For entry-level employees, it costs between 30 percent and 50 percent of their annual salary to replace them.
  • For mid-level employees, it costs upwards of 150 percent of their annual salary to replace them.
  • For high-level or highly specialized employees, it costs roughly 40 percent of their annual salary.

Slowing Down the Talent Drain

The traditional view says compensation spurs or stems employee turnover. While that’s sometimes the case, of course, the truth is that other factors such as autonomy, professional growth and organizational climate carry more weight.

There are no foolproof formulae that will quickly and easily solve employee turnover problems. But there are a number of evidence-based steps you can take that will help your situation and position your organization for success in the future. Typically, these activities fall into three general categories: communications, commitment and choice.

More – and more effective – communications

The first and most valuable action you can take to stem turnover is through more and more effective internal communications.

The old breakroom joke about employees feeling like mushrooms being fed manure in the dark may be trite, but it’s telling. No one likes to be uninformed about factors that affect their situation, so be sure to fill any information gaps before the grapevine of speculation takes root. It’s far better to exercise some control over how an issue or challenge is framed than to leave it to fate. As nature abhors a vacuum, so, too, do employees.

More than ever, it’s critical to be open and honest about your organization. Transparency and authenticity are today’s watchwords. If you expect to face financial challenges, be upfront about them and ask employees to help (note that’s “ask” rather than “order”).

Positive reinforcement such as praise for a job well done is also vital. Something as simple as a pat on the back for meeting a tough milestone can go a long way in making an employee feel appreciated. Better yet, send handwritten thank-you notes to individuals who performed above and beyond the call of duty to help the organization or a colleague.

Commitment to improve

Nearly all professionals – especially those in the healthcare field – want to feel part of something bigger that demonstrates a commitment to improve the future. That commitment can best be fostered through a positive and forward-thinking work climate.

Beyond scouring leadership books and business blogs (including this one, by the way) for ideas on how to strengthen your organization’s environment, it’s important to remember that your best source of information is your employees. While suggestion boxes may have gone the way of the manual typewriter, there are a number of new ways to gather employee input and encourage engagement.

One of the most innovative methods is called TinyPulse. Developed by University of California at Berkley and Wharton School of Business graduate David Niu, TinyPulse mails employees a weekly survey asking one question, usually about morale, benefits, retention or career progression. Rather than reading a typical once-a-year survey, managers are regularly kept informed by TinyPulse of any concerns or emerging issues. That way, they can take corrective actions before minor issues blow up into major problems that prompt valuable employees to walk out the door.

Another useful program developed by Linkedin cofounder Reid Hoffman recommends employers and their star employees to invest in one another. “Tour of Duty” suggests employers negotiate personalized plans through which employees have the opportunity to trans­form their careers by helping transform the company’s business. According to Hoffman, “the [LinkedIn] tour of duty isn’t a legally binding contract but an agreement that carries the strength of moral obligation. And because tours of duty are flexible, transparent, and highly personalized, they resonate well with Millennials.”

The Power of Choice

Few, if any, of us are comfortable without the power to influence our surroundings or situation. Because so much of what we do in the clinical research sector must adhere to rigid rules and regulations, it’s important for managers to find ways to offer employees some measure of independence and autonomy when possible (note: this is especially important among Millennials).

For example, the ability to work flexible hours or telecommute on occasion may be of more value than financial compensation to some of your employees. As more organizations adopt cloud-based study management platforms that provide easy access from practically anywhere at any time, it’s easier than ever to provide many of your team members with added flexibility in their day-to-day jobs. Letting workers set their own hours and/or work remotely (within reason, of course) may not only yield improved employee attitudes and performance, but it also can demonstrate your confidence and trust.

Will It Work?

There are no surefire ways to reduce employee turnover. What some need to stay put may be exactly what sends others running to the door. Different methods are needed for different employees, and constant changes in the world outside your organization demand flexibility and adaptability. By necessity, this is somewhat of a trial-and-error process. 

For many employees, the grass always appears to be a little thicker and a little greener just down the street.

The foundation of a healthy workplace – communication, commitment and choice – reflects what each of us values in our personal and professional lives. By focusing more attention and energy on these areas, you can help turn back the turnover that saps your organization of talent, spirit and success.


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Topics: Industry Insights, employee turnover

eClinicalOS v2015.2.0

Posted by Sean Farres on Mar 2, 2015 1:30:00 PM

We are pleased to announce the release of Merge eClinicalOS v2015.2.0 on Friday, February 27, 2015.  

Merge eClinicalOS v2015.2.0 includes information on the Medical Coding WHO drug enhancement as well as some other enhancements to existing tools.release_vids_thumb

We've also created Product Release Videos for the last several eClinicalOS updates (2015.1.0, 5.9.0, and 5.8.0). These videos will be made available from within the eCOS platform in the future. More information on that timeline to follow the next product release update. In the meantime, please contact us directly if you are interested in viewing our current collection of release videos!

Here are a few highlights in the upcoming release:

Medical Coding WHO Drug Enhancement

For all those who have asked, you can now include Preferred Term Code/Text in your medical coding module. After turning the option on in Design Attributes, the additional fields will be included in auto coding and available in the search results to be applied during manual coding. The values are included in the auto coding rules and data exports following the regular coding process. NOTE: This can be added to existing studies, but previously coded terms may need manual update to include the new information.

Study Blank CRF Languages

Subject Status report has been added to allow report access to the subject history record. The default view is the current subject status information, but optionally, the view can show all subject status records history. Additionally, a new ePRO report has been added to allow tracking of static ePRO records where a Begin rule exists - to identify completed versus missing records at a site level rather than by individual subject.

New Advanced Expression Editor Operators 

The Expression Editor is expanding to pull in information from your study to provide more targeted tools. The Advanced Expression Editor has been updated to include additional operators including:

  • Extracting a ‘substring’ of a value.
  • Determining if a page is marked deleted.
  • Include Cohort details such as 'Assigned', 'Factor Value', and 'Selected Cohort'.

These changes relate to suggestions from users base on additional details they would like to access for queries, calculations, and triggers. If you have more ideas, please let us know!

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

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Topics: Release Notes, advanced expression editor, release videos, medical coding

The Seven Deadly Sins to Avoid in EDC Adoption

Posted by Amy Young on Feb 25, 2015 4:54:49 PM

The Top Line:

  • Easily prevented mistakes can delay realizing EDC’s benefits
  • Effective EDC adoption requires careful planning and a step-by-step strategy
  • Adopting best practices can blunt seven common EDC missteps

Rowers

Picture this: Your organization just selected a killer EDC platform, and you are ready to build and launch your first study. Your team’s been trained, the logins and passwords are set, and everyone’s primed to get this puppy up and running. Greater efficiencies, bigger savings and faster trials are just around the corner!!

Unless, of course, they’re not.

Thing is, we’re all human, and we all make mistakes from time to time. Mistakes executing your first few EDC studies are not out of the realm of possibility, and those mistakes can delay realizing the system’s benefits (and cause massive frustration across the research team).

But with a little planning and preparation, you can sidestep the most common potholes of moving from paper to Cloud-based studies. Avoid these “Seven Deadly Sins of EDC Adoption,” and you’ll find yourself up and running at full EDC speed in a matter of weeks instead spinning your wheels in a roadside ditch.

Sin #1: Underestimate the time needed for training

Think of the interaction between people and technology as a bell-shaped curve. Some on our staff will take to the new system like ducks to water, while others will find themselves barely treading water in the deep end of the pool. It’s easy to misjudge the time your organization will need for training and implementation.

Moreover, training time varies widely among vendors. For some systems that are designed to be intuitive, your folks may only need a few days of training; other systems may require several weeks or even months to get everyone on the same digital page. Make sure this issue is near the top of your list of criteria when reviewing potential vendors.

Sin #2: Reach past the low-hanging fruit

Wanting to bring a new EDC system online quickly and tackle your thorniest challenges to reap its benefits is understandable. You want to confirm the vendor’s functionality claims, services and support as well as demonstrate the value of your investment. As with rolling out nearly any new technology or process, however, starting with a complex, high-stakes study increases the chance of an initial subpar performance (read: #researchfail).

If possible, plan to use the new system with less complex studies at first. There’s a reason low-hanging fruit gets picked first.

Sin #3: Fail to manage expectations

The leadership at organizations adopting EDC for the first time often have very high expectations of how the new system will perform, what its returns will be and how quickly those gains will be realized. Many anticipate new levels of efficiency and speed, and may be “underwhelmed” when longer training and implementation times translate into fewer gains on their first EDC study.

While it’s true some EDC platforms – especially end-to-end, Cloud-based systems built on a common interface – can yield immediate gains, that’s not the case with every system. Operational gains are real, but it likely will take a few trials before your team hits its stride. Make sure that fact is communicated early and often to your leadership team.

Sin #4: Try to use every function out of the gate

Nearly every feature during a product demo looks like it’s easy to use and will add value from the start. But that’s not true in every instance. It’s important that you carefully choose what EDC-related functions to deploy in your first few trials, especially if you expect to use different systems to manage different parts of your study.

Some EDC platforms offer scalable features via on-demand modules, enabling options to be selected or deselected at any time. Others don’t offer such flexibility and may require additional programming to ensure smooth data interfaces. Be sure to set firm criteria when reviewing vendor proposals and methodically evaluate which functions to deploy when.

Sin #5: Assess data only at the end of the study

Although final data sets may tell the most important story, EDC’s ability to provide up-to-the-minute data views affords you extraordinary power to monitor study progress. While you may not be able to tap statistically significant data in early phases of a study, you can track data quality and integrity on a daily basis to catch anomalies or workflow errors. Delivering data on a continuous basis is one of the primary advantages of cloud-based systems. Use it to your advantage.

Sin #6: Ignore built-in communication tools

Many EDC systems optimize communication among staff and stakeholders during a trial. Instead of relying on general email accounts to track and communicate study progress, integrated trial-related communication keeps all relevant and searchable information in one place. Often these capabilities are either overlooked or underutilized.  

A cloud-based system synchronizes data automatically, allowing the team to identify and communicate issues with data collection more rapidly. When key updates and directions are sent into already overstuffed inboxes, your team’s overall effectiveness is unnecessarily compromised.

Sin #7: Cling to old habits

To paraphrase an old maxim says, the definition of inefficiency is doing the same thing over and over and expecting different results. How you did things pre-EDC is not how you should do them now. While it may be uncomfortable for some on your team, it’s vital to adhere to proven best practices with EDC. Trying to integrate old paper-based workflows into an EDC platform is not only counter-intuitive, it’s counter-productive, as well.


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Topics: Industry Insights, EDC, edc adoption

Five Important Tasks You Can't Ignore When Switching to Cloud-Based EDC

Posted by Amy Young on Feb 18, 2015 9:00:00 AM

The Top Line:

  • More than 70 percent of clinical trials now use some form of EDC
  • Cloud-based EDC platforms offer significant benefits for all sizes and types of organizations
  • Selecting the best system for you requires careful due diligence in five key areas

Rowers

If there is an EDC genie, he’s permanently been let out of the bottle.

Well over 70 percent of clinical trials now use Electronic Data Collection (EDC) in some fashion since the first systems appeared a decade ago. And even if the pharmaceutical and medical device industry is historically slow to adopt new technology, the ease, efficiency and cost-effectiveness of cloud-based EDC platforms are encouraging upgrades across the sector.

CROs and investigator site early adopters, particularly in the U.S. and Europe, are taking the next step in clinical IT’s evolution: They’re moving away from older proprietary, server-based EDC systems, spurred on by streamlined data collection that improves data security, quality and access. This trend is especially evident among small and medium-size sponsors, CROs and academic research institutions that lack the capital needed to purchase, install and maintain server-based systems. And the market has responded as EDC vendors have added cloud-based tools to their product and service suites.

With all the advantages cloud-based systems offer, how hard is it to make the switch? It depends. Any change in technology will require a transitional period during which you’ll experience some measure of disruption. The key, then, is to conduct your due diligence in a way that will shorten the “return to normality” and speed your ability to capitalize on the new system’s benefits.

Before we jump in, a quick reminder: As you consider the alternatives, ensure every step in making the switch is identified and assigned a time value that are then built into a master project schedule. The system and vendor you choose should have internal experts who can shepherd the transition to ensure it is as smooth as possible and preserves the integrity and compliance of your data.

Outlined below are five key tasks that need to be at the top of your checklist when reviewing vendor proposals.

1. Data Transition

A secure cloud-based platform should easily accept and convert clinical data from multiple systems and sources – including EDC, CTMS, legacy studies, clinical research organizations and even MS Excel® files. More advanced cloud platforms will enable clinical team members from across the organization – in different countries and in their native languages – to import and interact with data whenever and however they choose. This function can be especially helpful for smaller research organizations that participate in international networks or are partnering with similar counterparts around the globe.

2. Compliance

Ask each vendor how its system supports validation and compliance, with a special focus on the following checklist:

  • 21CFR Part 11
  • 21CFR Part 5021CFR Part 54
  • 21CFR Part 312
  • 21CFR Part 314
  • 21CFR Part 820
  • 45CFR Parts 160, 162, 164
  • EU GMP Annex 11
  • FDA Guidance - Investigator Responsibility 
  • ICH E2A, ICH E3, ICH E6, ICH E8, ICH E9, ICH E2D, ICH E14
  • OHRP

It’s also important to confirm that a vendor’s platform adheres to the following:

  • 21CFR Part 11
  • EU GMP Annex 11
  • 45CFR Parts 160, 162, 164
  • 21CFR Part 820
  • FDA Guidance - Computerized Systems Used in Clinical Trials
  • FDA Guidance - General Principles of Software Validation
  • Any pertinent local and state regulations.

You also may want to ask whether a vendor is ISO-certified and has its FISMA accreditation.

These questions apply to any clinical system, whether it is cloud-based, hosted by a service provider, or installed on-site. Select an EDC system that is not validated out of the box, and your organization is on the hook to develop processes around your use of the system on your own.

3. Data Preservation and Security

Questions about the security of your data as well as its integrity and availability are natural when considering cloud-based systems. It’s critical that you confirm – in writing – that the provider you select operates a secure, hosted environment for your data to ensure uninterrupted access and performance.

It’s also important to ask where the data will be housed as well as the specific physical and electronic security measures the vendor uses. Further, you should ask the company to detail its encryption, data backup and disaster recovery protocols and verify how the data will be protected. If your data is located on a shared server, be sure to as how it will be isolated from other clients’ data. Most established EDC vendors whose products are used by the larger CROs and sponsors have this base covered in spades, so be sure to as about that “stamp of approval” when considering companies.

4. Regulations

The growing international scope of clinical trials raises the question of who can and should have access to and regulatory control of your study’s data. It’s likely the answer may depend on where the trial is conducted. For trials conducted in the U.S. and another country, ensure you confirm if the data must be hosted locally in that country. If so, be sure to have the vendors provide verifiable data on how and where they would host the data locally. (And even if your trials are not currently conducted outside of your country, you should consider these types of regulatory issues if you plan to expand your research footprint.) 

5. Beware of the Buzz

Using a cloud-based platform should promote ease of installation, training and use. Self-service design, scalability and pay-as-you-go arrangements are among the biggest advantages of these systems, especially for smaller research organizations.

But it’s critical to recognize there are different flavors of cloud installation – Software as a Service (SaaS), software applications available as standardized service over the Internet; Platform as a Service (PaaS), which provides functions for quick, cost-effective development and deployment of applications; and Infrastructure as a Service (IaaS), using virtual servers, which is the most basic form of cloud computing. Examine how each of these versions would fit your organization’s requirements and proceed accordingly.

You may come across providers that say they offer all the benefits of “the cloud,” but when push comes to shove, it turns out they offer something that’s not quite what was advertised (e.g., promoting a pay-as-you-go financial arrangement that actually requires you to sign up for a pre-determined spending commitment). 

It’s also critical that a vendor offers you the opportunity to take the software out for a test drive in a “real” environment. Unless you and your team can see what it’s actually like to use the product to build and manage a study, you may end up on the wrong side of a contract. (And speaking of contracts, if you can find SaaS vendors who offer an option to “turn off the spigot” without penalty, you’d do well to give them extra credit in the selection process.)

Adopting a cloud-based EDC system is not only a smart move for clinical research organizations, it’s very likely inevitable, as well. The days of costly, enterprise-wide system installations are quickly coming to an end (along with long-term contracts that locked you in for multiple years, no matter what).

Making the transition a successful one requires careful and methodical due diligence on your part. Pointed questions, detailed requests and an emphasis on evidence-based performance must be the foundation of your selection process. When the reputation of your organization’s ability to conduct accurate and cost-effective research is on the line, the most important rule of thumb to remember is a familiar one: caveat emptor – let the buyer beware.


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Topics: Industry Insights, Cloud, EDC

Changing Horses in Mid-Stream: Yes, You CAN Switch EDC Systems During a Trial

Posted by Amy Young on Feb 6, 2015 1:01:08 PM

The Top Line:

  • Sticking with outdated legacy EDC systems is no longer necessary even if your trial began with one. 
  • You can switch to more cost-effective EDC systems without delays, interruptions or increased risk.
  • Data-agnostic EDC platforms seamlessly import data from virtually any source.

Rowers

The advent of cloud-based EDC platforms has introduced unparalleled flexibility and speed into the clinical research process. With these sophisticated systems, sponsors now conduct studies of all sizes in every therapeutic area and location more easily and cost effectively than ever before.

But some sponsors are challenged “reaching for the clouds” because they believe that having an existing EDC system prevents them from moving to a better EDC platform.

It’s time to make the leap. Not only can today’s EDC platforms help you conduct smarter and more cost-effective studies, but many also can import your current study data quickly, accurately and effortlessly.

Can’t Get No Satisfaction 

Selecting an EDC system often was a trial in and of itself. The process most companies went through was designed to answer one question: “Will the system work the way we need it to?” Few asked the more important questions: “What if it doesn’t work? And if it doesn’t, how long will we be stuck with this broken-down nag?”

Put three sponsors in a room, and you can bet two of them have experienced “EDC Buyer’s Remorse” at one time or another. In general, their frustrations can be traced to two sources: the platform or the vendor (or both).

Problems associated with legacy EDC systems run the gamut. Some sponsors discover their software is outdated and can’t accommodate new demands such as remote access, mobile communications, inline translation and adaptive trial design. Others find their platform’s usability and functionality haven’t quite measured up to what was promised in the proposal. Complicated programming requirements cause delays and frustration; inadequate internal quality checks lead to data errors; and an inability to scale makes the system obsolete for growing organizations.

Other times, problems stemmed from vendors who didn’t deliver what was promised on time or in budget. Or the phrase “customer service” simply wasn’t in their vocabulary. Maybe they just assumed you wouldn’t switch to another system because you were so invested in theirs.

You do have a choice. You can switch to an EDC platform that is superior and more cost-effective with little risk or delay, even in the middle of a study.

Changing Systems Used to be Hard

The decision to change EDC platforms used to be a risky proposition for sponsors, especially if the new platform was another hard-wired, enterprise-level system. Implementation was complex (not to mention costly) and involved a raft of internal teams from clinical and IT to regulatory and purchasing as well as the new vendor, CRO partners and trial sites.

Operational issues such as database integrity, protocol amendments and study management concerns (such as enrollment status, forecasting and safety reporting) complicated the picture even further. Toss in months of additional training and the time needed to rebuild a study, and a decision to change horses in midstream was about as rare as a Triple Crown winner.

Data-agnostic Flexibility: Seamless Migration

Enter the data-agnostic cloud-based EDC platforms. Many are remarkably powerful and flexible systems that let you make on-the-fly adjustments during your study, including how you collect, manage and report data.

And if you choose a platform that’s “data-agnostic,” you can import data from virtually any source, including legacy systems, proprietary enterprise-level programs, open-source software and common spreadsheet programs such as Microsoft Excel®. This type of any-to-any visual data mapping, conversion and integration tool maps any combination of XML, database, EDI, XBRL, flat file, Excel, JSON and/or Web service and then converts the data instantly into the new system. Sophisticated algorithms seamlessly allow you to migrate to the new platform without compromising integrity, validity or time.

Back in the day, switching EDC platforms in midstream was difficult, risky and, if some cases, downright dangerous. Today, however, if your trial needs rescuing or you’re just tired of dealing with that old grey mare, many of the latest EDC platforms can alleviate buyer’s remorse and replace it with a proven winner.

You could even say that once you adopt that new system, you'll be off to the races.


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Topics: Industry Insights, EDC

Four Skills Every Site Manager Should Have

Posted by Amy Young on Feb 6, 2015 1:00:00 PM

The Top Line

  • Delivering value today requires clinical site managers to broaden and hone their skills.
  • Non-clinical skills such as leadership and communications are gaining importance.
  • Site managers must become proficient in advanced IT systems to stay competitive.

Rowers

Clinical programs have become increasingly complex given strong competition for productive sites, CRO consolidation, cost and time constraints, challenging internal and external environments, and large multinational stakeholders. Add to that a greater need to demonstrate how and why a drug will deliver value through every step of development, is it any wonder that when it comes to study execution more eyes are on the site manager?

Effective clinical trial management from the sponsor’s perspective and that of the individual st

udy site has its pressure points. Protocol development, IRB submissions, managing budgets, monitoring for compliance, facilitating proper data collection and preparing for a study audit all have to be planned and conducted flawlessly.

Where digital tools have altered the managerial and data collection landscape, clinical trial site managers’ skill sets have had to change, as well.

Skill Set #1: Leadership and Management

Site managers aren’t simply the location specialists for their particular sites that compete for business from sponsors and CROs. They need the “30,000-foot view” on the design, execution, analysis and reporting of studies while simultaneously overseeing patient care, contract negotiation, overhead and a host of other responsibilities. They are also facilitators, ensuring the success of a study with efficient information exchange among all internal and external stakeholders.

Effective facilitation by a site manager of a study’s operational aspects can significantly influence the success of the trial, from patient recruitment to final report submission. But site managers also must be effective HR facilitators. Attracting and retaining a top-notch professional staff requires the site manager have a firm grasp of training and mentoring to help ensure employees: (1) feel they are valued as individuals; and (2) are appropriately recognized for their individual contributions.

One of the most important leadership skills for a site manager to have is also among the least emphasized: communication. How information flows up, down and around an organization must be coordinated with forethought and planning if the site is to function at peak performance. It is critical that a site manager develop and implement a comprehensive internal communication program to ensure employees at all levels of the organization have the information they need to fulfill their specific job functions and, more important, work together as a coherent and unified team.

If you hear complaints such as “I never know what’s going on around here” or “If I had known about that three days ago, it would have saved me a lot of wasted time,” it’s time to reassess your communication practices and refocus your priorities, processes and programs. Effective internal communications do not happen just by chance nor can they be forced on an organization. Communications among employees should be timely, authentic, meaningful and purposeful. And perhaps most important to remember if you are a leader in the organization, effective communication starts at the top. If you don't walk the talk, it's likely many employees will talk more and more about walking out the door. 

Skill Set #2: Technology

Information technology advances in the healthcare sector are speeding up, and the trend has massive implications for site managers. The new breed of EDC tools, including mobile, Software as a Service (SaaS), and data integration and reporting capabilities, are making studies less costly and cumbersome to conduct and drastically improving data accuracy. And when the new industry normal is to demonstrate the value a new drug will deliver while it is still in development rather than after commercialization, it is time to up your game.

By its very nature, clinical research is technical and complex. But applying advanced data and study management software platforms and services can speed up, streamline and make the process easier. The technologist seeks the tools, systems and processes that will streamline site operations (study-related and non-study related) and improve efficiency, margins, quality and accuracy. As you establish your site as a center of excellence on all operational fronts, you increase your competitive advantage with current and potential clients and enhance your reputation as a “go-to” site.

Skill Set #3: Communications

With a hand on the productivity lever, a site manager must create and maintain an inclusive team that can answer any and all important clinical questions that arise before, during and after a study. Encouraging additional levels of communication about trial progress in general as well as progress within a given site can help encourage sustained involvement, commitment and attention to detail.

Listening and providing regular meaningful feedback ensure that staff members stay engaged. Managers must also tailor all communication appropriately to help busy clinicians identify and asses their individual priorities. Using an investigator's preferred method of communication (phone, email, website, text, etc.) can ensure he or she feels your communication is personal (which means he or she may be more inclined to pay attention to it).

Many current EDC platforms allow team members to communicate within the system itself. Messages and responses are logged into a database and recorded to confirm authenticity, adding an additional layer of quality assurance and reliability.

Skill Set #4: Risk Measurement and Response

Multiple risks can influence a study’s timeline, cost and quality. Deficiencies in any of these could degrade a site’s future attractiveness and reputation. Site managers should be on the lookout for slower than expected enrollment that may suggest study planning and protocols are not as robust as needed. In turn, that can lead to suppressed enrollment, missed targets, low awareness of the competitive landscape, and client concerns about the schedule of assessments.

Clearly, any one of these issues can lead to cost overruns; a combination of them can spell near-disaster for the site’s long-term reputation and profitability. Lackluster trial performance also can negatively affect a team’s performance, resulting in poor attitudes, lower productivity and higher turnover rates, not to mention compromised data quality. Site managers must identify and solve problems as quickly as possible and adjust seamlessly to their teams’ evolving roles and responsibilities.

In an era of ever-increasing client expectations and competitive pressures (not to mention rapidly evolving technology and approaches), simply maintaining the status quo is tantamount to throwing in the towel. As never before, you as a site manager must be prepared to handle virtually anything and everything that comes down the pike, whether it's related to a study or not.

The writing is on the wall (or more accurately, the pixels are on the screen): if you want to retain existing clients and attract new ones in the current environment, the most important value you can bring to the table is a sterling reputation. And the foundation of that reputation starts with you.


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You might also be interested in reading one of our FREE eGuides, "Crisis Communications Planning for Sites: Prepare for the Trial You Must Pass."

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Topics: Industry Insights, clinical sites, leadership, balance, communication

How EDC Improves Clinical Team Communication

Posted by Amy Young on Jan 28, 2015 2:06:00 PM

The Top Line:

  • EDC systems are becoming essential trial communication conduits
  • Optimize workflows and team interaction through modularization
  • Make use of EDC to advance corporate culture

RowersLook at your mobile phone. Do you have the latest, greatest app-laden smartgadget? No worries if you don’t. Using a device that is two or three generations old is no big deal.

In clinical research, though, it’s different. Ensuring your team has access to and is up to speed on the most recent data management software advancements is critical. Your technology backbone may not be on public display, but in a time of ever-expanding expectations, that backbone can make or break your ability to attract and retain clients.

EDC and digital communications are no longer considered novelties in clinical research. Besides improving data management and adherence to study protocols, the right EDC product can help improve delegation, reduce conflict and increase satisfaction and esprit de corps in your organization.

Comprehensive Message Tracking and Storage

EDC platforms can facilitate more effective – and selective – two-way communication among all staff members involved in a trial. And when communication is better across your team, the quality of their work and your organization’s performance will be better, as well.

Many software platforms now include internal communication tools that help teams stay in sync throughout the study’s lifespan. Functioning alongside other study management tools, these features log and store all trial-related communications within the EDC platform itself (rather than relying solely on your site’s general email system). Messages are searchable by date, subject, source and recipient as well as by keywords. Critical updates, protocol changes and assignments reside within the platform, helping ensure that important information and directions never get lost.

Modularization and Optimization

Similar to consumers who bypass cable service and select individual programs they want at a fraction of the usual cost, the latest generation of EDC software allows you to choose – and pay for – only those features you require, when you need them.

This modular approach lets you tailor the databases, workflows and communications precisely to your site and the specific trials you’re conducting from the get-go. The outcome is unparalleled information exchange among study staff that’s simplified and streamlined. Counterproductive reactions to protocol or process modifications (such as “Why didn’t anyone tell me about this before?”) are appreciably reduced through the enhanced communications and more immediate issue resolution these systems offer.

You can also optimize delegation by exercising control over who sees what. EDC systems integrate role-based permissions to access and modify files, saving time fulfilling information requests from other staff member and giving them access to information upon which they can act. This function also helps you ensure you stay on top of how the trial is progressing and who on your staff Is responsible for what.

Mapping Collaboration

EDC enables cleaner data creation and makes aggregating and directing the right information into the hands of the people who need it easier.

Think of EDC as Google Maps. Zoom in close, and you can examine the details of specific features, functions and outcomes. Pan out, and you can see how individual components interact with one another and easily identify significant patterns that otherwise might be hard to detect.

Seeing the bigger study picture in one place helps plot out the study plan, enabling clear lines of delegation across multiple sites and various levels of research staff (CRAs, nurses, doctors, technicians, etc.). Visibility into the entire trial permits study managers, clinical directors and investigators to spot potential issues earlier, set up internal checks and create reports to test and modify procedures.

The latest EDC platforms also can give a “street view” into your trials so you can examine specific aspects at a granular level. More user-friendly navigation and logic-based search options reduce frustration levels by helping you find exactly the data you want.

Manual vs. Automatic

Manual transmission cars can be a lot of fun on the open road. In rush hour, however, they can be a royal pain. Similarly, legacy EDC systems that require intensive manual data entry and manipulation can drag your study – and staff members – down.

Keeping the time between the end of data collection and implementation to a minimum requires deft synchronization. Non-cloud-based EDC platforms usually require time-intensive manual synchronization of data using equipment that’s hard-wired to the system.

A cloud-based system works differently. It automatically synchronizes the data directly to and from any Web-based device, allowing data managers to identify and communicate issues with the field team during data collection. This allows real-time data from all projects sites to flow from collection to implementation more rapidly.

Data and Team Building

As CROs add technology to their operations, different skill sets are emerging to increase efficiencies and streamline processes. Advanced IT that supports cross-functional talents and enhances cross-functional communication helps CROs and sites evolve and nurture their cultures to attract and retain the right kind of employees.

Just as you can load an app and access a world of information from your smartphone, evolving EDC capabilities let CROs do more, see more, and manage more to succeed in an environment that demands more. 


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Topics: Industry Insights, EDC, Crisis Communication Plan

eClinicalOS v2015.1.0

Posted by Dianne Chatterton on Jan 27, 2015 10:00:00 AM

We are pleased to announce the release of Merge eClinicalOS v2015.1.0 on Friday, January 30, 2015. This will occur at approximately 9:00 pm ET to reduce the potential impact to studies, but may cause a lag or disconnect for users. There will be 2 hours downtime (9 to 11PM EDT) while the update is made.V2-Exports_ByRevision 

Merge eClinicalOS v2015.1.0 includes uinformation on the new ZenDesk Integration as well as some other enhancements to existing tools.

Here are a few highlights in the upcoming release:

Temporary Unblinding

Unblinding actions can now be provided at two levels - study wide or subject information only - and the data can be viewed without formally unblinding the subject. Each request for access to unblinding subject information, page attachments, or site document attachments is recorded and can be exported as an audit trail table. NOTE: Existing users with access to unblinding information may now have to click a button to access rather than viewing on screen.

New Study Reports

A Subject Status report has been added to allow report access to the subject history record. The default view is the current subject status information, but optionally, the view can show all subject status records history. Additionally, a new ePRO report has been added to allow tracking of static ePRO records where a Begin rule exists - to identify completed versus missing records at a site level rather than by individual subject.

ZenDesk Integration

ZenDesk is a platform for collecting and tracking issues and for providing support resources. In January 2015, our internal tracking system is being integrated with eClinicalOS so that external users will be able to access its tools. You will be able to report issues, track their resolution, and access the Knowledge Base from links within eClinicalOS.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

Login to eCOS

 

Topics: Release Notes, Temporary Unblinding, Study Reports, ZenDesk

Why Move Your Trial From Paper to the Cloud

Posted by Amy Young on Jan 15, 2015 3:17:00 PM

The Top Line:

  • Today's EDC platforms are more scalable and powerful than in years past.
  • Innovative billing structures allow researchers of any size to use EDC.
  • The FDA encourages EDC adoption.

The popularity of EDC (Electronic Data Capture) continues to grow throughout the clinical research sector. EDC technology now is common not only in large pharmaceutical trials, but also in smaller biotechnology and device studies. At the same time, though, a number of small sponsors and clinical research organizations (CROs) believe EDC is still beyond their budgets and continue to enter paper Case Report Forms (CRFs) into electronic databases (double data entry). They also often enter paper CRFs into spreadsheet programs like MS Excel® for trials where submission to the FDA is not the ultimate goal.

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But the evidence is clear: recent advancements in EDC technology combined with new pricing models have put EDC within reach of virtually all clinical researchers for all sizes of studies. And it’s clear that the more open and immediate collaboration and data access EDC fosters among sponsors, regulators and CROs through electronic communication reduces research costs and helps bring safer, more efficacious products to market sooner.

So in an industry that’s evidence-based, what are the facts supporting EDC adoption?

EDC is Faster

Cloud-based software offers everything CROs and sponsors need to develop and execute studies more quickly and successfully. Efficiencies are gained every step of the way, from data transmission and cleaning to data monitoring and reporting. Furthermore, the days when building databases with EDC took months and months are long gone. Today’s digital tools let you design and launch trials much easier and much faster (sometimes in as few as 10 days, in fact). Databases can be created without the intermediate step of building paper CRFs first.

EDC is More Accurate

Optimizing trial management through technological components such as digital identities, digital signatures and cloud storage makes collection, retrieval and review of clinical data easier, effective and better managed. A single system that collects and stores all your data assets (e.g., eCRF data, images, PDF source documents, etc.) saves time by enabling you to search the data in a clinically meaningful context and store it all in an organized manner. Further, EDC platforms help ensure data accuracy at the point of entry through automated edit checks that alert you to potential errors immediately.

EDC is More Cost Effective

The productivity gained by eliminating the countless hours spent searching binders to file or retrieve one document (much less several hundred) is a well-known advantage of EDC. But early EDC systems that required steep upfront infrastructure investments and long-term contracts put such advantages out of reach for many researchers. Today many cloud-based platforms allow you to use only the tools you need, when you need them. With this “pay-as-you-go” option, EDC technology now can be leveraged for trials of all sizes. Some systems let you customize the blend of features you need and pay based solely on what you use and how long you use it. 

EDC Means Data Portability

You can access today’s cloud-based EDC platforms with any Web-enabled device, and the software will automatically optimize your interface to match your tablet or smartphone. The systems are validated against the most frequently used Web browsers, and some vendors even allow you to create customized alerts that help you stay on top of study data and changes. As in other aspects of your life, you are no longer tied to your desk to conduct work; you can take your study and all its data with you wherever you go.

EDC is Global Trial Friendly

Because many cloud-based platforms allow users to select their native language for system navigation and CRF display, it is much easier to collect data on one common platform across all sites, regardless of location. Some vendors also incorporate “features of convenience” that automate the process of source document translation so team members who speak different languages can collaborate more easily.  

The FDA Supports EDC

Years ago, the FDA expressed concern that EDC technology might conflict with long-standing rules and regulations. That caution led many researchers to forego adopting EDC. Well, the days of “EDC foot-dragging” are long gone. In 2013, the FDA released Final Guidance on Electronic Source Data in Clinical Investigations in which the agency outlines EDC’s many benefits and encourages its adoption. If you haven’t read the report yet, it is definitely worth your time.  

In 2015, access to affordable, powerful, scalable and secure data management platforms is growing. Technology that once may have been too pricey for smaller trials or research groups is now available at a fraction of the cost. If it’s been a year or more since your organization last reviewed EDC options, that is an investigation worth conducting. 


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Topics: Industry Insights, Cloud, EDC

Three Trust Markers In 2015

Posted by Amy Young on Jan 7, 2015 11:48:00 AM

How will your CRO fare in 2015? It depends on how your sponsor companies manage a bevy of industry challenges. R&D costs, pricing pressures and regulatory developments are part of the mix.

It’s these areas that pharmaceutical and biotechnology sponsors will deliberate to find the right balance and manage resources between in-house and outsourced projects. But three markers could make your 2015 more competitive and profitable.

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Sponsor Spending

Good news: budgets are still heading up. After a period of static R&D investment, spending is on the rise again. While we’re waiting to see the upcoming industry 2015 outlook stories, the positive trend lines predict another year of climbing outsourcing budgets. Back in February, CenterWatch broke down global drug development spending and found that R&D has shifted to smaller companies, among other compelling findings.

CROs that are seeking to capitalize on international growth must understand the operating landscape that is rapidly emerging across China. As of June of this year, the World Health Organization reported there were 10,248 registered trials. While it is a mere fraction of the trials conducted in the U.S., growth in China’s research sectors are among the world’s fastest and is estimated to grow at 18 percent annually to $767 million by 2016.

Growth Management

With growth can come delay. The numbers are well known, but they bear repeating.

According to the National Institutes of Health, the amount of registered trials since 2000 has increased nearly 30-fold to more than 170,000. Ninety-four percent of studies experience delays, and nearly three out of four are delayed by more than one month. Drug development now costs more than $1 billion, and each day a trial is delayed costs a sponsor $8 million.

Study design complexity and how sponsors handle intricate protocols and newer regulations will be brought to bear on how studies are executed. But as reliance on CROs has grown, so has dependence – and reliance – on the Cloud, which is being recognized as a viable source of business value. 

The latest technology trends include more efficient methods of study execution and site selection to advance clinical development. It’s what the Tufts Center for the Study of Drug Development predicted would happen in 2012.

Partnership Development

Large pharma is benefiting from strategic partnerships as they plan their drug development efforts over the course of years to dramatically reduce costs, and as noted in a recent Industry Standard Research study, small to medium sized CROs can offer valuable services at highly competitive price points. 

Although technology will continue to play a transformative role in driving operational efficiencies, biopharma companies very much value the human captial component of a strategic partnership. The demand for the right people and business chemistry is noted in numerous industry studies, which should shape how small and medium CROs position their business development strategy going forward.

While the big, institutionalized players will merchandize their deep, scientific resources and extensive support systems, the smaller companies are almost cottage industries. It’s here you can shine. Bring everyone in your operation out front and center. Let the sponsor meet and get to know who exactly will be managing and executing the study from start to finish, building confidence and trust.

Industry growth is all but certain for 2015. Unless your competitors have skills that are truly unique, excellent technical capabilities will go only so far. Your sponsors are looking for someone they can trust.


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You might also be interesting in reading one of our FREE Ebooks "Catch a Wave and You're Sitting On Top of the World: How Information Technology is Leveling The Playing Field".

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Topics: Industry Insights

The Power of Clinical Partnerships

Posted by Amy Young on Dec 15, 2014 3:30:00 PM

The growing complexity and required efficiency of today’s clinical studies demand teamwork inside and across organizational lines. Building the most effective partnerships, though, requires experience, focus and an unselfish attitude. Applied Clinical Trials spoke with our President, Zaher El-Assi, about how to build a smart, sustainable partnership in clinical research.

"The Power of Clinical Partnerships"
Our President Zaher El-Assi, shares lessons learned and the core practices Merge eClinical uses to forge long-term partnerships that produce value for both companies that goes beyond the traditional buy-sell relationship.

An eClinicalOS White Paper & podcast.

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from our friends at

Applied Clinical Trials

 

or

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Topics: Merge eClinical, CRO Partnerships, Applied Clinical Trials

eClinicalOS v5.9 Release

Posted by Dianne Chatterton on Dec 3, 2014 3:30:00 PM

We are pleased to announce the release of Merge eClinicalOS v5.9 on Friday, December 12, 2014. This will occur at approximately 9:00 pm ET to reduce the potential impact to studies, but may cause a lag or disconnect for users. There will be 2 hours downtime (9 to 11PM EDT) while the update is made.V2-Exports_ByRevision 

Merge eClinicalOS v5.9 includes updates to the advanced expression editor as well as some other enhancements to existing tools.

Here are a few highlights in the upcoming release:

Predictive Resupply

eClinicalOS v5.9 harnesses functionality from our legacy IxRS products to provide enhanced inventory management.  This functionality is based on the traditional floor/ceiling method but includes additional parameters to allow the system to better track site inventory.  This new feature is optional and requires minimal setup. 

Advanced Expression Editor

New operators in the Advanced Expression Editor continue to expand your ability to set conditions for system queries, automatic calculations, visit schedule rule triggers, and optional modules.  Highlighted in the release, is  ToNumeric, which allows designers to use code values as numbers to calculate a score based on codelist responses.  Also included is Coalesce, which helps simplify expressions by handling non-null conditions.  In addition, the previous restrictions to expression length have been removed to allow more complex conditions to be defined.

Email Management

eClinicalOS generates many email notifications that are useful during study conduct, but can be cumbersome or confusing during development and testing.  With eClinicalOS v5.9, designers will now be able to temporarily suspend emails for a study.  This is an optional tool for your study teams, but a direct response to feedback from many users.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

Login to eCOS

 

Topics: Release Notes, Platform Updates, Predictive Resupply, advanced expression editor

PPCE Selects eClinicalOS for Rheumatoid Arthritis Trial

Posted by Dianne Chatterton on Nov 19, 2014 10:15:00 AM

PPCE selected the eClinicalOS data management platform from Merge eClinical for a rheumatoid arthritis study for a Singapore-based pharmaceuticals company. While the number of eClinicalOS-based trials outside the U.S. has grown steadily since its launch in 2012, this study represents the first time the platform has been used to administer a trial in India. Visit the Merge Healthcare News Page to download a copy of the release!

"PPCE Selects eClinicalOS for Rheumatoid Arthritis Trial".

  cover_page

Click here to download

this press release

 

Topics: Merge eClinical, News Release, Rheumatoid Arthritis Trial

Verthermia Selects eClinicalOS for Whole Body Hyperthermia Ovarian Cancer Treatment Trial

Posted by Dianne Chatterton on Nov 6, 2014 10:30:00 AM

Verthermia, Inc. has selected eClinicalOS from Merge eClinical for its clinical trial exploring the potential of whole body hyperthermia as a standalone treatment for women with Stage III or IV ovarian cancer. Visit the Merge Healthcare News Page to download a copy of the release!

"Verthermia Selects eClinicalOS for Ovarian Cancer Treatment Trial"

  cover_page

Click here to download

this press release

 

Topics: Merge eClinical, News Release, Cancer Study

eClinicalOS v5.8 Release

Posted by Dianne Chatterton on Oct 28, 2014 12:30:00 PM

We are pleased to announce the release of Merge eClinicalOS v5.8 on Friday, November 7, 2014. This will occur at approximately 9:00 pm ET to reduce the potential impact to studies, but may cause a lag or disconnect for users. There will be 2 hours downtime (9 to 11PM EDT) while the update is made.V2-Exports_ByRevision 

eClinicalOS v5.8 includes the introduction of a brand new module called Cohorts as well as some other enhancements to the existing tools.

Here are a few highlights in the upcoming release:

Cohorts

This release introduces the Cohorts Module which provides the capability to group together subjects with similar demographics or medical history data. Cohorts also minimizes the impact stratification factors may have when analyzing trial outcomes. In addition, both randomization and drug inventory become more efficient when Cohorts are in use.

The Cohorts module allows Client Administrator users to manage and administer the module without the assistance of a study designer. This, in turn, empowers study users to monitor results and make changes as required.

Planned Studies

A new reminder has been added to help account and financial administrators manage budgets and planning. The system will provide a message on the login page prompting users to review and update their planned studies, including start/end and status.

Medical Coding

A new Medical Coding Study Report has been added to enable you to review CRF data and coding data in the same listing. The views within the module have also been updated to enhance filters, sorts, and navigation.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

Login to eCOS

 

Topics: Release Notes, Platform Updates, cohorts

Benefits of CTMS for Clinical Research Centers

Posted by Amy Young on Oct 23, 2014 9:46:00 AM

To achieve success, all organizations must master operational efficiency and financial management fundamentals.  For research organizations, balancing financial management with the rush of patient and study activities is a major challenge.  Fortunately, with the right Clinical Trial Management Software (CTMS), any research center (regardless of its size) can build a successful business foundation quickly, while improving the patient experience, bottom line, and the job satisfaction of staff and providers.

Using the lifecycle of a study, Kelli Paull, our Director of Business Development for Merge eClinical's Research Site Market discusses five major aspects of the clinical trial process that are improved by the use of CTMS.  Contract negotiation, study and budget set-up, patient recruitment, invoicing and cash application, and reporting.

"The Benefits of CTMS for Clinical Research Centers".

A Merge eClinical article in SCRS Insite Magazine, Quarter 3 Issue. 

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from our friends at

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Topics: Merge eClinical, SiteCTMS

Clinical Trials Tools For All!

Posted by Amy Young on Sep 2, 2014 1:30:00 PM

ClinicalTrials.gov lists studies that span the entire United States plus nearly 200 other countries. That shows the intensity of activity around the world in clinical trials. Despite the complexity of modern clinical trials, new technologies open this field to more participants. Our President, Zaher El-Assi, talked with Applied Clinical Trials to discuss how information technology is leveling the clinical research playing field.

"Clinical Trials Tools For All"
Merge eClinical delivers sophisticated technology that benefits any user.

An eClinicalOS White Paper

book

Download the white paper

from our friends at

Applied Clinical Trials

Topics: Merge eClinical, Applied Clinical Trials

Hey sites: this one’s for you!

Posted by Sean Farres on Aug 19, 2014 10:30:00 AM

Successful Sites = Successful Studies

We are pleased to announce the release of Merge CTMS for Investigators v4.2.

A study is only as successful as its sites.  A well-organized site – one that can find information quickly, manages recruitment and financials effectively – can grow its research operation and become a better partner to pharma.  That’s where clinical trial management software for Sites comes in.  Whether you’re an eClinicalOS site looking for ways to centralize and organize your study operations, or a sponsor or CRO eClinicalOS partner looking to help your sites improve, take a look at our CTMS for Investigators Solution.  We just released Version 4.2 of CTMS for Investigators, including new tools to help sites track their entire research business more effectively.  Check it out!

Here are a few highlights in the release:

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Copy Study

Are there similarities between your newly-awarded Study and a Study you’ve already set up? Instead of adding the new Study from scratch, save time using the new Copy Study feature!

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Import Patients:

Are you manually typing in Patient Demographics from another system into Merge CTMS? Now you can import Patient Demographics directly from an Excel spreadsheet.

Enrollment_Performance

Enrollment Performance:

Have you assessed your Site’s enrollment performance across all of the Studies you’ve conducted? Merge CTMS now calculates your cumulative Percent-to-Quota for both closed-to-enrollment and open-to-enrollment Studies.

 Financials

Financial Setup:

Have you checked out the Financial Setup screen lately? It provides easy access to Invoice Defaults and soon you’ll be able to enter a Sponsor or CRO address once and then pull it into any Study’s Invoice Defaults.

Click here to see our new features in action! 

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Director of Business Development Kelli Paull at Kelli.Paull@Merge.com 

To learn more, visit us at www.eclinicalos.com/CTMS 

Topics: Release Notes, Platform Updates, Enrollment Performance, Copy Study, SiteCTMS, Import Patients, Financial Enhancements

eClinicalOS v5.6.4.0 Release

Posted by Sean Farres on Aug 12, 2014 10:00:00 AM

V2-Exports_ByRevisionWe are pleased to announce the release of Merge eClinicalOS v5.6.4.0 on Friday, August 22, 2014. This will occur at approximately 9:00 pm ET to reduce the potential impact to studies, but may cause a lag or disconnect for users. There will be 2 hours downtime (9 to 11PM EDT) while the update is made.

eClinicalOS v5.6.4.0 includes updates for new rules and reports as well as some other enhancements to existing tools.

Here are a few highlights in the upcoming release:

New Rule: Visit Time Window Rule

This allows the designer to set a target date for a scheduled visit. Visits must have a visit date identified on the Visit Schedule and must be non-repeating. Working with the Advanced Expression Editor, users define the earliest possible date to begin the visit (Start) and the last possible date to conduct the visit (End) in relation to the target.

New Rule: Periodic Send Alert

This allows the designer to set email reminders for visits that have a Visit Time Window Rule. You can include an optional trigger, defined in the Advanced Expression Editor. You can also define the periodicity of the email - daily, weekly, or monthly.

New Report: Visit Timeline

This report starts with the target date information for each selected visit for each subject. A status of due, overdue, performed inside window or performed outside window is assigned based on the visit window definition. Subject identifiers and selected remote values can be included. The report can be set for visit level or subject level and includes links.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

Login to eCOS

 

Topics: Release Notes, Platform Updates, Reports

eClinicalOS v5.6.3.0 Release

Posted by Sean Farres on Jul 14, 2014 2:01:00 PM

V2-Exports_ByRevisionWe are pleased to announce the release of Merge eClinicalOS v5.6.3.0 on Friday, July 18, 2014. No downtime is expected; however, users may be required to login again during the upgrade process.

eClinicalOS v5.6.3.0 includes updates and enhancements to the data exporting tool to expand content and processing options. The previous data export settings are designated as Version 1 and are the default for existing studies upon the release of eClinicalOS v5.6.3.0. 

The new data export options are available on Design Attributes (Optional) as Version 2 and include options for revision or incremental generation of exports. Both versions have the same formats, scheduling, and transfer options.

Login to your account to read the full external release notes, detailing the changes you will see in the system. This document is available on the landing page for study designers after the release. The updated manuals and self-study training materials will also be available at that time.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

Login to eCOS

 

Topics: Release Notes, Platform Updates, Data Exporting

Catch a Wave and You're Sitting On Top of the World

Posted by Amy Young on Jun 13, 2014 6:55:00 PM

Advances in information technology are revolutionizing how sponsors, CROs and academic institutions design and manage clinical studies. The development of affordable, secure cloud-based software services such as eClinicalOS is helping researchers in all settings conduct studies of any scope more quickly and cost-effectively. As this trend accelerates, the importance of an organization's size, budget and existing technology infrastructure on its ability to conduct trials will steadily decrease. This paper explores how the success of the Software-as-a-Service (SaaS) model in leveling the competitive playing field in other industries can be duplicated in the clinical research sector.

"Catch a Wave and You're Sitting On Top of the World"
How Information Technology is Leveling the Playing Field

An eClinicalOS White Paper

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from our friends at

Fierce BiotechIT

Join us at DIA

Posted by Dianne Chatterton on Jun 13, 2014 3:25:00 PM

convention-center-image-blog

Join Merge eClinical in San Diego for this year's Drug Information Association 50th Annual Meeting. The event is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development, and life cycle management of medical products all with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

Stop by Booth #1319 for a token of our appreciation! Also, test drive eCOS and be entered to win a FitBit Flex! 

June 15-19, 2014
San Diego, CA


For more information about this year's show, please visit http://www.diahome.org/en-US/Flagship-Meetings/DIA2014.aspx 

Topics: Trade Shows

eClinicalOS v5.6.1.0 Release

Posted by Sean Farres on Jun 13, 2014 2:08:00 PM

We are pleased to announce the release of Merge eClinicalOS v5.6.1.0 on Saturday, June 14, 2014. This will occur at approximately 9:00 am ET to reduce the potential impact to studies. There will be 2 hours downtime (9 to 11AM EDT) while the update is made.

eClinicalOS v5.6 includes features for two new modules that are in development as well as some other enhancements to existing tools.

Here are a few highlights in the upcoming release:

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New eClinicalOS Website

We will be relaunching the main eClinicalOS website with this next release. The new site will feature all of our latest-greatest news and upcoming events we have to share along with many helpful resources to keep you better connected with our eCOS community.

micro_login

New Secure Login Page

With the launch of our new eClinicalOS website, we have also updated the look and feel of our secure login page. Functionality has not changed - though we think you will like the cleaner layout.

 

NEW TOOL: Advanced Expression Editor

Auto Calc Field controls, Cross Page/Other System Queries, and Data Value Visit Schedule Rules rely on expressions to determine how and when they function. With the release of eClinicalOS v5.6.1.0, a new expression tool is being released.

Login to your account to read the full external release notes, detailing the changes you will see in the system. This document is available on the landing page for study designers after the release. The updated manuals and self-study training materials will also be available at that time.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

Login to eCOS

 

Topics: Release Notes, Platform Updates

Eurotrials Selects eCOS as Technology Partner

Posted by Dianne Chatterton on Jun 11, 2014 9:14:38 AM

Partnership strengthens presence in European and Latin American markets; Merge eClinical Solutions expand footprint to open data center in Brazil

splasheuroMorrisville, N.C.  (May 19, 2014) – Merge Healthcare Incorporated (NASDAQ: MRGE), a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced that Eurotrials, a full-service clinical research organization with expertise in Europe and Latin America, has selected Merge  as its technology partner of choice to focus on expanding their presence in Europe and the burgeoning Latin American market.
 
As part of the agreement, Merge will create a data center in Brazil to serve Eurotrials’ researchers in the region and train them as certified providers of the company’s solution, Merge eClinicalOS™ (eCOS), a unified platform utilizing a pay-as-you-go, self-run environment to manage and run studies.  
 
Dr. Maria Queiroz, Global CEO with Eurotrials, said the partnership makes sense on a number of levels. “First and foremost, both our firms thrive on cultivating a climate of collaboration and innovation to serve the needs of a fast-evolving market. eClinicalOS enables Eurotrials to help our clients stay on top of new trends in risk assessment such as remote and risk-based monitoring.”
 
According to Dr. Queiroz, the integration of functions such as embedded translation, automatic medical coding and electronic patient reported outcomes in eClinicalOS significantly boosts her firm’s ability to manage studies across borders seamlessly. “And the fact that eCOS empowers data managers with no programming experience to design studies on their own is extraordinarily valuable,” she said.
 
“One of our primary goals in 2014 is to expand our international business, and we couldn’t have found a better partner for this effort. We are honored and excited to partner with a company of Eurotrials’ profile and prestige,” said Zaher El-Assi, President of Merge eClinical. “Our eCOS solution has a strong presence in the U.S. and European markets and we certainly expect to see continued growth in those regions.”
 
Justin Dearborn, CEO of Merge, continued, “A key strategy for us is penetrating markets where advanced clinical study management technologies such as eClinicalOS are not yet commonplace. Joining forces with a prominent CRO that is universally recognized for its expertise in Latin America is a huge benefit for Merge and will allow us to continue to expand our global footprint.”


 

About Eurotrials 
Eurotrials is a privately owned full-service CRO focused in Europe and Latin America markets with strong local expertise. The company has been validated by international biopharmaceutical companies, has several master agreements and is ISO- 9001 certified. With nearly 20 years of experience, Eurotrials has offices in Portugal, Brazil, Argentina, Chile and Spain and presence in Peru, Colombia, Mexico and several European countries. Eurotrials provides an extensive array of services from early- to late-stage research as well as product support in accordance with global and specific regional requirements. Innovative models of collaboration with the biopharmaceutical and device industry, research institutions and clinical research sites are the main drivers of Eurotrials’ development strategy.
 
About Merge
Merge is a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare. Merge’s enterprise and cloud-based technologies for image intensive specialties provide access to any image, anywhere, any time. Merge also provides clinical trials software with end-to-end study support in a single platform and other intelligent health data and analytics solutions. With solutions that have been used by providers for more than 25 years, Merge is helping to reduce costs, improve efficiencies and enhance the quality of healthcare worldwide. For more information, visit merge.com and follow us @MergeHealthcare.

Cautionary Notice Regarding Forward-Looking Statements
The matters discussed in this news release may include forward-looking statements, which could involve a number of risks and uncertainties. When used in this press release, the words “will,” “believes,” “intends,” “anticipates,” “expects” and similar expressions are intended to identify forward-looking statements. Actual results could differ materially from those expressed in, or implied by, such forward-looking statements. Except as expressly required by the federal securities laws, the Company undertakes no obligation to update such factors or to publicly announce the results of any of the forward-looking statements.

Contact:
Aaron Mazze
Vice President, eClinical Marketing
Merge Healthcare
919.653.3467
Aaron.Mazze@merge.com

Interested in learning more about eCOS? No better way than to jump right in!

Start a Study

Topics: Merge eClinical, Brazil CRO, CRO Partnerships

eClinicalOS v5.6 Release

Posted by Sean Farres on Apr 30, 2014 11:24:00 AM

ecos_thumbnailWe are pleased to announce the release of Merge eClinicalOS v5.6 on Friday, May 2, 2014. This will occur at approximately 9:00 pm ET to reduce the potential impact to studies. There will be 2 hours downtime (9 to 11PM EDT) while the update is made.

eClinicalOS v5.6 includes features for two new modules that are in development as well as some other enhancements to existing tools.

Here are a few highlights in the upcoming release:

Study Manager Module

The Study Manager module will integrate trial management tools into eClinicalOS. With this release, you will be able to add and track milestone events in development and conduct. You will also be able to upload and track documents for the study. Both tools can be used at a site level or study level.

DICOM/Imaging Module

The DICOM/Imaging module will integrate medical images into eClinicalOS. With this release, you will be able to designate types and upload corresponding images to the CRF page. You will also be able to view the images with the iConnectAccess viewer.

Future releases will expand the tools available in these modules.

Other Updates

eClinicalOS v5.6.0.0 also updates the Visit Schedule Page Permissions to enable easier add, modify, and delete of permissions, adds some additional output to SAS exports, and adds a new study document that outputs the study audit trail in CSV format for review.

Login to your account to read the full external release notes, detailing the changes you will see in the system. This document is available on the landing page for study designers after the release. The updated manuals and self-study training materials will also be available at that time.

Need Assistance?

If you have questions or concerns about the impact of the update on your studies, please contact technical support team 24/7/365.

• Email: eclinicalhelp@merge.com
• Toll Free: (888) 500-4247
• Local: (919) 653-3400

Need A Demo?

If you would like a short demonstration of the new features, please contact your account manager or our Inside Sales Director Bruce Avery at bruce.avery@merge.com.

Login to eCOS

 

Topics: Release Notes, Study Manager,, Platform Updates, DICOM, Imaging

Bio-IT World Conference & Expo

Posted by Dianne Chatterton on Apr 3, 2014 10:46:33 AM

Join Merge in Boston for this year's Bio-IT World Conference & Expo. The event plans to unite 2,500+ life sciences, pharmaceutical, clinical, healthcare, and IT professionals from 30+ countries. The Expo provides the perfect venue to share information and discuss enabling technologies that are driving biomedical research and the drug development process.

April 29 - May 1, 2014

For more information about this year's show, please visit http://www.bio-itworldexpo.com/

Topics: Trade Shows

ACRP 2014 Global Conference & Exhibition

Posted by Dianne Chatterton on Apr 3, 2014 10:33:17 AM

Join Merge eClinical in San Antonio for the single largest gathering of clinical research professionals in North America.

April 26 - 29, 2014

Visit us at Booth #515

For more information about this year's show, please visit http://www.acrp2014.org/

Topics: Trade Shows

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