Endpoint Clinical Selects Egnyte to Enhance IRT Audit Logs for Clinical Trials
Wakefield, Mass., and Mountain View, Calif., October 20, 2022
Wakefield, Mass., and Mountain View, Calif., October 20, 2022
Endpoint Clinical, a leader in global interactive response technology (IRT®) for clinical trials, and Egnyte, the secure platform for content collaboration and governance, today announced that Endpoint Clinical has partnered with Egnyte, providing a Google Cloud-compliant platform to establish a secure file server that can share IRT audit logs directly with Investigators post study close.
“Sponsors in regulatory inspections are cited frequently for not adhering to guidelines from health authorities, in regard to providing Investigators with direct audit log access for data oversight,” said Cat Hall, VP Data and Quality, at Endpoint Clinical. “IRT vendors are being asked to provide audit log extracts directly to Investigators to ensure data integrity. With limited means to share data outside of the traditional IRT system, we needed to work with a technology solution that could supply IRT audit logs straight to Investigator sites to ensure compliance. Egnyte was able to deliver on that and more.”
Egnyte helps life science organizations manage content-rich workflows that come with clinical studies, regulatory submissions, and more, maintaining compliance with industry regulations. Working with Egnyte, Endpoint Clinical has created a validated system that extracts IRT audit log data for each site and directly provisions the data files to investigators in the secure GxP-compliant platform.
“For highly regulated industries like life sciences, maintaining the validity of documents is essential,” said Ronen Vengosh, Vice President of Life Sciences at Egnyte. “Egnyte’s GxP-compliant solution gives these organizations the ability to manage their documents and maintain audit readiness with detailed audit trail reporting for data integrity.”
To learn more about how Endpoint Clinical has enhanced its IRT solution with Egnyte, visit www.endpointclinical.com/audit-data-management.
About Endpoint Clinical
Endpoint Clinical is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. For over a decade, their team of professionals has been working to continuously evolve their suite of randomization and trial supply management (RTSM) technologies to help Sponsors achieve clinical trial success. Their dynamic IRT solution, PULSE®, for patient randomization and management, site management, and drug supply management and comprehensive clinical supplies management tool, DRIVE, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Wakefield, MA, with offices across the US, EU, and Asia.