Over the past 18 months, moving from established processes and protocols to remote, decentralized trials posed many challenges for clinical trial Sites, CROs and Sponsors. Despite the investment in remote connectivity and technology, not all software solutions are designed to deliver audit readiness.
"During an FDA surveillance inspection of our site, the inspector was able to collect the required regulatory documents in less than an hour with Complion. And the inspector had no findings." - Susan Bonner, BS, RPh, Regulatory manager, Tekton Research, Inc.
Read more about our client, Tekton Research, and their experience moving from paper to a “no findings” FDA inspection.