THE TOP LINE
In clinical research, confidence comes from clarity.
With IBM Clinical Development, you can choose from a range of options to help you see your study more clearly — and manage it more smartly. Through our exclusive Clinical Configurator™, you simply click-and-pick the capabilities that best fit your research needs. So you get what you need — without having to pay for what you don’t.
Capabilities available within the IBM Clinical Development platform include the following:
Ad-hoc reporting module helps you create robust ad hoc reports. The data visualization tool allows for the design and build of standard and custom reports that can pull data from any field as well as related metadata.
Cohorts allows you to better replicate in your study how a new drug may be used in practice (i.e., in real-world settings) with specific patient groups. In turn, you’ll be better positioned to minimize the impact that the differences in those groups may create when you’re analyzing outcomes of your trial procedures. [Learn More]
Some data for clinical studies cannot be captured digitally, and some sponsors use multiple vendors to collect all the information they want for a study. The Data Imports option lets you add data to the study EDC without performing data entry (e.g., central lab results that can be provided electronically to the sponsor). The information is imported into IBM Clincial Development and integrated with the rest of your data. API services provide a way to monitor the study or use imports in an automated fashion, increasing your study team’s efficiency. Imports allows you to add data without data entry through SFTP or create web service/API that will upload data directly and map it to CRF. Training program on how to use DI/API available.
The DICOM tool lets you upload, store and view medical images directly into the IBM Clinical Development platform. The module includes a page control for uploading and identifying different types of images such as MRI, CT or PET. A Storage/Data/Retrieve tool is included for image management needs, and you can view any image with iConnectAccess, a zero-download DICOM image and XDS viewer.
allows you to define treatment options, to input and track inventory, shipments and site inventory, and to dispense to your subject database. Dispensing details and all relevant shipping information from the shipper to the subject are included in your study’s data exports with each subject’s record.
This module lets you specify that data is entered twice, a common practice when case report forms are collected in paper form or where best practices require that data be entered twice to help ensure accuracy.
At its core, IBM Clinical Development offers a fully integrated and comprehensive pathway to capitalize on the robust benefits of an EDC system. Beyond just eliminating wasteful and time-consuming paper records, though, the IBM Clinical Development EDC function empowers you to track, monitor and improve operational efficiency while ensuring compliance with all necessary regulations. Best of all, the IBM Clinical Development platform puts every piece of study data at your fingertips through a consistent, integrated interface accessible from virtually any Web-enabled device.
Unique in the industry, our online adjudication tool saves time and money by enabling you to bring true “paperless workflow” to endpoint adjudication. No more boxes of three-inch-thick notebooks to ship, no more verifying thousands of data points by hand. Instead, you capture source docs and endpoint details as part of a streamlined electronic workflow that facilitates adjudication of endpoints and events, including safety endpoints. You can also collect the information and then provide access to electronic dossiers and forms to sites, coordinators and adjudicators. And you can track progress of the review from a convenient one-stop dashboard.
Essentially a digital diary, Electronic Patient-Reported Outcomes (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. Because ePRO is a browser-based system integrated into the overall platform, both patients and researchers can access the data anywhere, anytime.
The IBM Clinical Development Inventory Management and Dispensing module provides an up-to-the-minute status overview of your research inventory and lets you coordinate the entire dispensing and tracking process in a comprehensive and coordinated manner.
With reliance on local laboratories growing, study teams must collect lab-specific normal ranges to use the data provided. But those labs’ formats, content and test methods often vary, making it difficult to ensure consistency and accuracy. Lab Normals helps normalize laboratory values to account for data differences between various clinical research sites. This module collects ranges, applies them to subject results for cleaning, and then outputs the data as a regular study export. Want to learn more?
Through this module, you can access MedDRA and WHO Drug dictionaries (based on licensure), capture the text verbatim, and research and assign codes (you can even output the codes in the same export as original study data). Plus, you can select or update your dictionary version to suit your study needs. (learn more)
Monitor Management is a collaborative digital environment that helps site monitoring teams become more productive and efficient. With Monitor Management, you can create site visit templates, define several site visit plans, track visit activities, generate instant trip reports, and more. No more filling out paperwork or wondering what the team is doing – it’s all there, all online.
Monitoring Levels is a targeted source data verification (SDV) tool that helps further reduce the monitoring burden. With this feature, a variety of 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. And Monitoring Levels becomes even more powerful when it’s paired with our signal-driven Risk Based Monitoring (RBM) capabilities.
Our Randomization module is an Interactive Web Response (IWR) feature that lets you define the stratification factors used to select and assign subjects to a randomization group. You can also assign randomization records to subjects directly in EDC and have the information included in the same data export. [Learn More]
Through a partnership with Remarque Systems, IBM Clinical Development offers access to the industry’s most comprehensive and powerful Risk-Based Monitoring (RBM) platform. Remarque RBM is a knowledge engine that uses machine learning and statistical algorithms to predict, detect, analyze and manage risk. With this intuitive, workflow-enabled and audit trail-supported environment, researchers can identify and address potential risks before they become problems. [Learn More]
Our Safety Reporting module allows you to generate reports for your study. You can create a readable ICSR report and post it to an eCRF page – or use the submission process to transfer it outside of the system. The module outputs adverse event forms in a standard E2B format.
The Site Documents module allows you to attach key documents sites may need to reference quickly (e.g., study protocol, charter documents, work instruction, etc.). You can also attach any document anywhere in the system in a meaningful context (i.e., at site, patient and field levels). (The Site Documents module is a native function of IBM Clinical Development.) [Learn More]
Powered by SAS Visual Analytics (VA), our Smart Reports module creates single-study and cross-study reports that help you draw better visual and logical conclusions across data sets. Through a state-of-the-art analytics visualization platform, Smart Reports lets you uncover fresh insights, patterns and relationships in your data that may not be obvious. Customized expressly for clinical researchers, Smart Reports is fully integrated into our industry-leading IBM Clinical Development® (IBM Clinical Development) platform. [Learn More}
With the Source Data Verification function, you can choose any clinical data field to be indicated as “Source Data Verified” when building your study. As a result, you can implement monitoring plans based on a specific target percentage of data to be verified. (Source Data Verification is a native function of IBM Clinical Development.)
Through this easy-to-use mobile application, you have fingertip access to study data such as charts, graphs, reports and key metrics. In addition, the Study Connect mobile app lets you set customized alerts and notifications (e.g., when an adverse event occurs, when a site is activated, when a subject is enrolled, etc.). Even randomization, dispensing and site document capture can be handled on your on iOS®-enabled devices (iPhone® or iPad®) with this app. [Learn More or Download from Apple iTunes]
When you find “research” and “the business of research” intersecting (and they always do), you’ll find our Study Manager module to be an ideal ally. Through Study Manager, you can track performance not only in a single trial, but also across your portfolio of trials. It offers an array of valuable functions, including: (1) tracking progress milestones related to site activation; (2) storing site and study-related documents with certain version control capabilities; (3) creating and storing site monitoring visit reports; and (4) tracking financial data (e.g., study budgets and site payments). You already run a great trial; now you can run a great business, too. [Learn More]
The Training/Tracking module lets you require that users such as clinical trial coordinators and investigators review training material (e.g., study protocol, work instructions, etc.) and pass an online assessment before they’re allowed access to the system. Many clients use this feature to demonstrate FDA-training compliance at research sites.
Our translation module allows you with one click to seamlessly include additional language access in your study. Simply design your page. Import non-English translations. And watch the system do the rest, as it automatically provides the appropriate view based on the user’s language choice.
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