Independent clinical judgment
The review is conducted independently from real-time medical monitoring and site operations. It assesses whether subject-level records support the clinical decisions reflected in study data.
Clinical Governance & Ethics
Governance principles for independent physician-led clinical assurance
The service is designed to provide structured physician review of selected subject records while maintaining independence, defined scope, and evidence-based documentation standards.
Defined scope and documented limits
Reviews are sampling-based, focused on defined objectives, and documented with stated scope and limitations. Absence of findings does not imply absence of issues outside the reviewed sample.
Sponsor responsibility remains unchanged
The service is audit and advisory in nature. Sponsors retain responsibility for trial conduct, participant safety, medical monitoring, regulatory compliance, and follow-up actions.