YPrime Advanced eCOA Oversight

Clinical trials depend on investigator oversight to protect participant safety and ensure data integrity. As global regulations evolve, the expectation for documented, attributable review of participant data has become clear—manual sign-offs and paper records are no longer sufficient.

At YPrime, our Advanced eCOA Oversight brings this essential function into the digital workflow. Principal Investigators (PIs) can securely review, acknowledge, and sign off on participant data, creating a complete electronic record of supervision that helps clinical trial sponsors and research sites demonstrate investigator accountability with accuracy and transparency.

Key Capabilities That Strengthen Oversight

YPrime’s Advanced eCOA Oversight supports the regulatory expectations defined by EMA, FDA, and ICH E6(R3). It provides documented, attributable records of investigator review, ensuring that oversight is auditable, secure, and consistent across all 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 

Learn More About YPrime eCOA

Explore how YPrime Advanced eCOA Oversight enhances compliance and participant safety in every study. Complete the form to download the fact sheet or request a demo.