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Service Highlights

  • Implementation Planning

  • Feasibility, SOW, project definition and terms of reference

  • Author validation plan

  • Update user requirements specifications (URS) document

  • Author traceability matrix

  • Author/update PQ scripts to include client-specific workflows

  • Dry-run and update PQ/UAT scripts in a custom environment

  • Performance qualification and user acceptance training scripts with documented execution results for official validation documentation

  • Author validation summary report

Validation offerings include:

validation planning

Validation Planning

Implement a comprehensive author validation plan to document the overall approach and strategy for the implementation and validation of your Trial Interactive products.

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User Requirement Specification (URS)

User Requirement Specification (URS)

Establish a comprehensive user requirement specification (URS) with a TransPerfect validation consultant (VC) for your dedicated instance of Trial Interactive to document your customer-specific intended use.

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Functional Requirement Specification (FRS)

Performance Qualification and User Acceptance Test (UAT) Scripts

Work with a TransPerfect validation consultant to author, execute, and review your PQ/UAT scripts. Your validation consultant will dry-run and update PQ/UAT scripts in the customer’s environment in order to identify any potential incidents during official execution. Receive completed PQ/UAT scripts with documented results of the PQ/UAT execution for the official validation documentation.

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quality reports

Validation Summary Reports (VSR)

Compile granular documentation of the results of all phases of the implementation and validation project.

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Download Trial Interactive’s IT Fact Sheet

For IT professionals who are considering Trial Interactive's seamlessly connected solutions, this fact sheet will be an invaluable resource in the decision-making process. Whether you're looking to streamline your clinical trial management or scale your operations, our eClinical platform has the tools you need to succeed.

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Supporting Your Risk-Based Strategy
We recognize every company has different validation strategies, but each one is based on regulations and GAMP guidelines. The goal of our validation package is to provide your team with additional objective evidence to support your risk-based validation strategy.
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FROM SITE IDENTIFICATION TO CLOSE-OUT, CLINICAL DOCUMENT PROCESSES AND OPERATIONAL OVERSIGHT ARE COMPLEX. OUR ELECTRONIC TRIAL SOLUTIONS SIMPLIFY YOUR CLINICAL OPERATIONS: EXPEDITE TIMELINES, ENABLE COLLABORATION, IMPROVE QUALITY, CAPTURE THE FULL STORY OF STUDY, AND PASS INSPECTIONS.

eTMF and TMF Solutions

eTMF and TMF Solutions

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Content Management

Content Management

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Trial Management

Trial Management

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Learning Management

Learning Management

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