MALVERN, PA — YPrime, a clinical trial technology company, has introduced Advanced eCOA Oversight, a new feature designed to improve how principal investigators review, verify, and sign off on participant data. The update enhances accountability and regulatory compliance by embedding electronic oversight directly into the company’s eCOA (electronic Clinical Outcome Assessment) platform.
The new functionality aligns with the latest guidance from the European Medicines Agency (EMA) and the International Council for Harmonisation (ICH) E6(R3) standards, both of which emphasize traceable, documented investigator sign-offs to ensure data accuracy and participant safety.
Advanced eCOA Oversight provides secure, attributable electronic signatures compliant with 21 CFR Part 11, automated prompts for re-signatures when data changes, and detailed audit-ready reporting that captures review timelines and signature histories. These features replace traditional paper-based workflows that have long slowed clinical operations.
“YPrime’s Advanced eCOA Oversight represents the next evolution of our platform—giving investigators and sponsors greater visibility, faster access to verified data, and a more efficient path to study delivery,” said CEO Ian Lennox. Aubrey Verna, Senior Product Director of eCOA, added that the feature ensures “investigator oversight is traceable, attributable, and electronic,” reflecting the direction of global regulatory agencies.
The rollout follows several recent enhancements to YPrime’s platform, including AI-powered localization, automated data change forms, and glucometer integrations. The company was also named a Leader in Everest Group’s 2025 eCOA PEAK Matrix® Assessment, reinforcing its position as a top provider of scalable, high-quality eCOA solutions for global trials.
With the launch of Advanced eCOA Oversight, YPrime aims to simplify investigator compliance while strengthening data integrity—advancing its mission to make clinical research more transparent, efficient, and patient-centered.
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