YPrime Advanced eCOA Oversight

Clinical trials depend on clear, documented investigator oversight to protect participant safety and ensure data integrity. As regulatory expectations from the EMA, FDA, and ICH E6(R3) continue to evolve, manual sign-offs, scanned documents, and paper-based records are no longer sufficient to demonstrate supervision.

Clinical trials depend on clear, documented investigator oversight to protect participant safety and ensure data integrity. As regulatory expectations from the EMA, FDA, and ICH E6(R3) continue to evolve, manual sign-offs, scanned documents, and paper-based records are no longer sufficient to demonstrate supervision.

Built to Meet Modern Regulatory Expectations

YPrime Advanced eCOA Oversight is designed to align with regulatory guidance from the EMA, FDA, and ICH E6(R3), supporting continuous, traceable oversight across the clinical trial lifecycle. Oversight actions are captured electronically, time-stamped, and preserved in an audit-ready state—without adding administrative burden for sites.

Attributable Reviews ensure data accountability and regulatory readiness

Automatic Re-Review Prompting maintains data integrity and a clear audit trail for changes to data

Audit-Ready Reporting simplifies inspection and documentation

Integrated Workflows reduce site burden and operational delays 

Why Advanced eCOA Oversight Matters

Without digital oversight, sponsors risk gaps in attribution, timing, and documentation, issues auditors are trained to identify. By embedding oversight into the eCOA platform itself, YPrime helps sponsors demonstrate investigator accountablility, reduce compliance risk, protect data integrity, and more.

Discover how YPrime Advanced eCOA Oversight supports regulatory compliance, participant safety, and confident trial execution. Complete the form to download the fact sheet or request a demo.