Best Practices For Preparing For Your TMF Inspection

By Gillian Gittens, Director of eClinical Strategy and Solutions, TransPerfect Life Sciences, Trial Interactive

The clinical trial regulatory inspection—among the most pivotal steps in reaching approval—is going through an evolution. Regulatory authorities across the globe are updating their requirements to keep up with new eClinical technology, the increasing complexities of clinical trials, and a new, unexpected variable: COVID-19.

As the pandemic has made on-site inspections challenging across most of the world, remote inspections have become vital to keeping studies moving forward. How does this change the way we prepare for inspections, and how do we address the new challenges a remote inspection could bring?