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Digital technologies and AI are transforming pharmacovigilance, clinical documentation (eTMF), and regulatory operations.
What This Means for You:
- Review data-governance policies and AI tool validation.
- Ensure electronic signatures and traceability meet GxP expectations.
- Train staff on AI-assisted document review and PV data management.
New functionality aligns with EMA, FDA, and ICH E6(R3) expectations for documented investigator review, endorsement, and sign-off of participant data
MALVERN, Pa., Oct. 29, 2025 (GLOBE NEWSWIRE) — YPrime, a proven leader in clinical trial technology, today announced the launch of its Advanced eCOA Oversight functionality—a key enhancement to its eCOA platform designed to simplify and strengthen how Principal Investigators (PIs) review and acknowledge participant data.
Recent updates from the EMA Guideline on Computerized Systems1 and ICH E6(R3)2 emphasize that investigator oversight must be documented, attributable, and demonstrable, including electronic review and endorsement of study data at predetermined milestones. These frameworks reinforce the investigator’s responsibility to maintain data integrity, ensure participant safety, and confirm the accuracy and completeness of data submitted to sponsors.
YPrime’s Advanced eCOA Oversight addresses these evolving regulatory expectations by embedding a compliant, auditable signature workflow directly into the eCOA platform.