January 30, 2024
Poor Operational Efficiency Drives the Need to Increase Startup and Protocol Amendment Implementation Speed
MALVERN, PA – YPrime, a clinical trial technology partner specializing in eCOA, IRT, and patient engagement solutions, today released new research examining how operational inefficiencies in eCOA are impacting clinical trial startup timelines, protocol amendment execution, and overall study performance.
The adoption of electronic Clinical Outcome Assessment (eCOA) platforms in clinical trials continues to grow, driven by their ability to improve data accuracy, enhance participant compliance, and streamline endpoint collection. However, as clinical trials become more complex, operational friction within eCOA implementations is increasingly contributing to delays, risk, and execution challenges.
YPrime’s research highlights the operational realities clinical teams are facing today—and why eCOA operational efficiency has become a critical priority for sponsors and CROs.
Key Findings: eCOA Operational Challenges in Clinical Trials
- Top Concerns Clinical Trial Professionals face with eCOA
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- Timelines/Delays (62%)
- Data change capabilities (50%)
- Protocol amendments (41%)
- Protocol Amendment Frequency in Recent Clinical Trials
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- 1-3 Protocol amendments (52%)
- 4-6 Protocol amendments (35%)
- 7+ Protocol amendments (13%)
- How Clinical Teams Measure eCOA Endpoint Collection Success
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- Visit compliance status (79%)
- Diary/scale compliance status (77%)
- Patient enrollment status (65%)
These findings underscore a clear industry challenge: while eCOA adoption is widespread, many platforms struggle to support fast study startup, efficient protocol amendments, and flexible data change management—directly impacting trial timelines and data quality.
“As clinical trials grow more complex, operational efficiency is no longer optional—it’s essential,” said Mike Hughes, Chief Product Officer, YPrime. “This research highlights how startup delays, protocol amendments, and limited data change capabilities continue to slow trials down. At YPrime, we focus on designing eCOA solutions that anticipate change, support real-time execution, and reduce operational risk throughout the study lifecycle.”
YPrime’s survey of clinical stakeholders provides insight into how sponsors and sites evaluate eCOA performance, where friction persists, and what capabilities matter most when executing trials under real-world conditions. Organizations looking to improve eCOA operational efficiency can download the full report here: COA Trends for Today and Tomorrow.
About YPrime
At YPrime, we pioneer solutions that streamline the clinical trial journey, increasing certainty from study design to data lock. With a foundation built on decades of industry insight and expertise, we are inspired by the life-altering outcomes unlocked by clinical trials. Our dedication to quality is pivotal in propelling the groundbreaking endeavors of our partners, researchers, and investigators. With a technology platform that enables speed, flexibility, and certainty for large and emerging pharma companies alike, we provide eConsent, IRT, eCOA, and patient engagement solutions that solve for certainty in clinical research.
Media Contact
Grazia Mohren, Head of Marketing, YPrime, marketing@yprime.com