Case Study: Endpoint Clinical achieves more compliant audit data submission with Egnyte

Endpoint Clinical Achieves More Compliant Audit Data Submission with Egnyte

Endpoint Clinical, an Interactive Response Technology (IRT) provider, faced a compliance challenge at trial closeout: how to securely deliver audit trail data to investigators and regulators without making sponsors act as intermediaries, which could raise data integrity concerns. The company used Egnyte’s cloud file solution to support more compliant audit data submission in a highly regulated clinical trial environment.

Working with Egnyte, Endpoint Clinical built an Audit Data Management platform that enabled direct, controlled audit log delivery with traceability, granular access permissions, and documented proof of distribution. The result was a more secure and compliant process that helped ease regulators’ concerns, gave sponsors oversight without hands-on involvement, and made Endpoint Clinical more attractive to sponsors and investigators, with stronger confidence in ALCOA-plus compliance.

Endpoint

Cat Hall

Vice President of Data and Quality