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eSRA is a common tool across sites and sponsors for assessing the readiness of site systems to be used in the conduct of regulated clinical trials
This document is intended to provide information (in addition to the eSRA Handbook) to sponsors/CROs in deciding to implement eSRA for evaluating a site system’s readiness to provide regulatory-acceptable data and documents for their clinical trials.
Europe/Hybrid Autumn Workshop, October 27-29, 2026, Zurich, Switzerland, hosted by BSI Software
eCF Webinar November: FDA warning letters for audit trail analytics
FDA warning letters tell us what went wrong, but what could your audit trail analytics program have caught earlier? Join our upcoming webinar for a practical, in-depth look at an FDA warning letter and learn how to identify missed signals, uncover blind spots, and strengthen your audit trail review program.