Scaling Trust in Highly Regulated Clinical Trial Platforms
Industry:
Healthcare
Region:
Nebraska, USA
Technology:
Selenium, BDD Cucumber, HP ALM, Java, SQL Server
About the Client
A fast-growing life sciences technology company providing clinical trial and lab data platforms, used by global pharmaceutical firms for compliance, data integrity, and operational visibility.
Challenges
Operating under strict regulatory frameworks, the client’s QA processes needed to be foolproof. Challenges included:
- Manual test execution delaying FDA documentation approvals
- High volume of forms and dynamic validations in clinical trial workflows
- Unavailability of test data at scale for repeated test cycles
- Lack of traceability between test cases and validation documentation
Solutions
Evoke implemented a Cucumber BDD automation framework layered on top of Selenium and integrated with ALM tools, aligning with GxP and 21 CFR Part 11 compliance standards.
- To solve FDA documentation delays, test case execution and reporting were automated, and validation outputs were archived with digital timestamps
- For dynamic form validations, automation scripts were built using Selenium’s dynamic locator strategies and field-level assertions
Results
- Reduced test documentation time by 75%
- Reduced test execution time for core workflows by 80%
- Enabled audit-ready reporting within 2 hours post-test run
- Achieved FDA validation in a record 6 weeks
