eCOA Case Study: Preserving Data Quality During a Protocol Amendment

How do sponsors maintain data quality and regulatory confidence when protocol amendments threaten clinical trial timelines?

A global pharmaceutical sponsor faced this exact challenge during a Phase 3 oncology clinical trial. Mid-study protocol amendments introduced two new electronic Clinical Outcome Assessments (eCOAs) and additional treatment arms—changes that significantly increased operational complexity and risk to data integrity.

With active patients enrolled, global sites operating on different regulatory timelines, and inspection readiness at stake, the sponsor needed an eCOA partner capable of managing protocol amendments without disrupting data quality or patient assessments.

The eCOA Challenge: Managing Protocol Amendments and Data Integrity

Protocol amendments are among the most common causes of data inconsistency, site confusion, and delayed timelines in global clinical trials. In this case, YPrime identified gaps between the written amendment and the operational requirements needed to execute it correctly within the eCOA system—risks that had not yet been detected elsewhere.

YPrime implemented a structured, proactive eCOA amendment strategy designed to preserve data quality while keeping the trial on schedule:

Strategic Planning of Clinical Trial Protocol Amendments — Learn how YPrime developed a multi-phased plan aligned with non-simultaneous regulatory approvals.

Data Integrity Solutions — Discover techniques to maintain quality when implementing complex changes mid-study.

Comprehensive Documentation — See how thorough documentation protects patient safety and regulatory compliance.

Enhanced Site Support — Explore how detailed guidance helped sites implement new assessment requirements without compromising data.

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