YPrime Launches Advanced eCOA Oversight to Strengthen Investigator Accountability and Participant Safety
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.
The functionality supports:
- Attributable Signatures: Each electronic sign-off is securely tied to the individual investigator, maintaining 21 CFR Part 11 compliance.
- Re-Signature Capability: When data is changed after prior sign-off, the system automatically prompts the PI to review and re-sign, ensuring data continuity and traceability.
- Demonstrable Oversight: Investigators can review and acknowledge participant data at their convenience within the eCOA platform.
- Audit-Ready Reporting: Oversight reports capture electronic data review, signature history, timestamps, and data changes for inspection or submission.
“YPrime’s Advanced eCOA Oversight represents the next evolution of our eCOA platform—giving investigators and sponsors greater visibility, faster access to verified data, and a more efficient path to study delivery,” said Ian Lennox, Chief Executive Officer at YPrime. “It’s a strong example of how we continue to anticipate what sites and regulators need, while enabling trials to run with greater confidence and control.”
By digitizing the PI acknowledgment process, YPrime eliminates the need for manual print-and-sign workflows that have long burdened clinical research sites. Investigators can now fulfill their regulatory responsibilities within a single, secure system that records every review and endorsement in real time.
“Regulatory agencies are making it clear that investigator oversight must be traceable, attributable, and electronic,” said Aubrey Verna, Senior Product Director of eCOA at YPrime. “This feature ensures those expectations are met, streamlining oversight while maintaining the highest levels of compliance and data integrity.”
This launch extends YPrime’s commitment to innovation that accelerates compliance and operational excellence, while improving the experience for participants and sites. Recent eCOA enhancements—including YPrime’s AI-powered eCOA localization, Automated Data Change Forms (DCF), and glucometer integrations—underscore the company’s mission to advance science and health by simplifying clinical trials, empowering sponsors to launch faster, with high quality data, and stronger participant engagement.
YPrime was recently named a Leader in Everest Group’s 2025 eCOA PEAK Matrix® Assessment, recognizing the company’s proven ability to deliver scalable, high-quality eCOA solutions that meet the speed and complexity of today’s global clinical trials. This latest release builds on that leadership, demonstrating YPrime’s continued investment in clinical trial innovation. YPrime was also previously recognized as a Trailblazer in Patient Engagement by Everest Group in 2024, underscoring its commitment to creating digital tools that make clinical trials more intuitive, patient-centered, and efficient.
Sources:
1. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf
2. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
About YPrime
YPrime simplifies clinical trials with eCOA, IRT, and eConsent solutions that combine speed, flexibility, and quality. The YPrime eCOA platform enhances participant compliance with an intuitive app and easy-to-use design, streamlines site workflows through a powerful eCOA portal, integrates seamlessly with connected devices, and supports sponsors with dashboards for better decision-making. AI-supported eCOA localization accelerates globalization, while pre-validated and configurable eCOA and IRT deliver faster study startup with quality metrics above industry standards. Trusted by top pharma leaders and emerging biotech companies alike, YPrime blends deep industry expertise and innovation to deliver reliable solutions. With nearly two decades of proven success, solutions in 250+ languages, and support in 100+ countries, YPrime is your partner to solve clinical research challenges with certainty. Visit www.yprime.com or email marketing@yprime.com.
Media Contact
Grazia Mohren
Senior Vice President, Marketing, YPrime
marketing@yprime.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5eb61691-4244-42d1-a152-fda76bf56207
YPrime Launches Advanced eCOA Oversight to Strengthen Investigator Accountability and Participant Safety
New functionality aligns with EMA, FDA, and ICH E6(R3) expectations for documented investigator review, endorsement, and sign-off of participant data
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