We Offer a Variety of Services to Support Your Trials

   

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Study Testing

Before you can “go live,” you’ve got to “go test.”

 

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Quality and Compliance

See how IBM Clinical Development can work in every corner of your office.

What We Support

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Save time training site users on study needs, and explaining workflows while walking your users through role-specific videos. 

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Study Testing


The secret to engineering excellence isn’t complicated. It’s built on two pillars: smart design and thorough testing. Before you can “go live,” you’ve got to “go test.” Fortunately, the study testing module from IBM Clinical Development makes that a smooth process from the word “go.” You can manually design and deploy a wide range of custom test cases tailored to your workflow and specifications. You can even scan one study design and replicate other cases based on that design.Study Testing

 
 IBM Clinical Development offers:

Automated scenario creation for both complete studies and fit-for-use delta scenarios
Capitalizes on study testing documentation that’s embedded within the platform and tracked
Manages your testing configuration and workflow to conform to your SOPs/processes

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Quality and Compliance


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Maximum transparency, data integrity, cross-validation - it’s all here at your fingertips. IBM Clinical Development supports the full range of regulatory guidelines 

  • IBM Clinical Development is Safe Harbor and ISO-certified, 21CFR Part 11 adherence
  • Fully supports all GCP and associated regulations
  • Advanced tools such as the V-Room (a Virtual Audit) help control costs
  • 21CFR. MedDRA. OHRP. ISO.

What We Support- What We Follow

  • 21CFR Part 11- 21CFR Part 11
  • 21CFR Part 50- EU GMP Annex 11
  • 21CFR Part 54- 45CFR Parts 160, 162, 164
  • 21CFR Part 312- 21CFR Part 820
  • 21CFR Part 314- FDA Guidance - Computerized Systems Used in Clinical Investigations
  • 21CFR Part 820 -FDA Guidance - Computerized Systems Used in Clinical Investigations
  • 45CFR Parts 160, 162, 164- FDA Guidance / General Principles of Software Validation
  • FDA Guidance Investigator Responsibility - Local, State Regulations
  • ICH E2A, ICH E3, ICH E6, ICH E8, ICH E9, ICH E2D, ICH E14- Local, State Regulations
  • OHRP- Local, State Regulations

Built-in Compliance Features:

IBM Clinical Development has two built-in compliance features to support your study: a Vendor Qualification Audit and a Study Audit.

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Custom Training Videos


build-study-icon_IBM.pngWith Customized Video Training from IBM Clinical Development, you’re able to train your site users on your specific study needs. Explain workflows, site actions and expectations while walking your users through role-specific videos, viewing exactly what they see and do before they need to do it.

With our Custom made training videos, IBM Clinical Development can:
  •  Produce videos tailored to your team’s unique needs, processes and learning interests for IBM Clinical Development.
  • Saves staff time.
  • Utilizes our training tracking module to manage and prove site training 

Where to Begin?

How about a “Getting Started” video that puts your team on the right path right from the start? Or dive straight in to any of these topics:

Role-based system use and instruction

Understanding queries and intra-study communication

Instructions (by role) on how to receive or complete assigned tasks

Understanding your workflow

General guidelines for entering and signing data

System navigation and help

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