Wakefield, Mass., and Mountain View, Calif., September 29th, 2022 – Endpoint Clinical, the 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 of 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,
Egnyte is the secure multi-cloud platform for content security and governance that enables organizations to better protect and collaborate on their most valuable content. Established in 2007, Egnyte has democratized cloud content security for more than 17,000 organizations, helping customers improve data security, maintain compliance, prevent and detect ransomware threats, and boost employee productivity on any app, any cloud, anywhere. For more information, visit www.egnyte.com.