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Providing a Seamless Approach to Validating Clinical Trial Data

Accelerator
  • Life Sciences & Healthcare

Fast Facts​

  • While other companies have developed their own approaches to systems validation and verification of clinical trial data, EPAM’s automation framework ensures tech solutions used by pharma companies are compliant with FDA requirements and continue to meet requirements over time
  • The automation framework consists of a standard HTML result template used to capture screenshots and detailed steps of all tests executed for a release and can be reused across different projects and clients to capture results

If you would like to learn more about the framework and how EPAM can help you develop a Clinical Trial Data Management System, download our Clinical Trial Data Automation Framework one-pager or contact us today.

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Benefit & Value

EPAM has been deploying software validation solutions since 2011 and never had any reported issues from the FDA or system users. Our Clinical Trial Data Automation Framework has increased automation coverage from 5% to more than 85% throughout our history and has increased the number of product releases from two to four per calendar year.

How It Works

  • The multi-layered framework spreads across client applications for validating the platform across an end-to-end system
  • The approach tests an entire platform by validating every scenario at the product level and limiting the study validation scope to a study-specific workflow
  • The reduced test cycle time for application releases maintains high quality software standards
  • The increased automation test coverage includes all positive and negative cases as part of a test bank     
  • The detailed HTML test results are published at the end of the automation script execution to show traceability from requirements, test scenarios, user action, expected result, actual result and screenshots to comply with FDA regulation 21 CFR Part 11
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Validating Clinical Trials
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Developing a Drug Information Database
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