Inspection & Audit Preparation In Decentralized Trials

Decentralized clinical trials (DCTs) are expanding the potential sources for collection of clinical trial data. To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. While DCTs have changed the data collection landscape, the core elements of an inspection have stayed the same and Sponsors must ensure these new data capture technologies are fit-for-purpose. This article covers the several areas for consideration to ensure audit readiness from start-up through submission.