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How To Achieve a “No Findings” FDA Inspection Utilizing Remote Site Access

Tekton Research

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.

eReg/eISF Solutions for Clinical Trials

› No More Paper Binders

Reduce costs, avoid redundancy, and increase staff productivity.

› Improved Efficiency

Easily archive, get eSignatures, and view files from anywhere or from any device.

› Audit Ready

A built-in audit trail ensures accuracy and eliminates study conduct and patient safety risks.