The Value Of Artificial Intelligence To Support Inspection Readiness

By Angela Skipper

During the Momentum GCP (Good Clinical Practice) Inspection Readiness conference in December 2023, there was a session focused on the utilization of Artificial Intelligence (AI) in bolstering inspection readiness (IR) for clinical trials.

During the presentation, it was highlighted that conducting a Health Authority (HA) inspection for a clinical trial is an unpredictable event, emphasizing the paramount importance of preparation for a smooth process that often serves as a precursor to obtaining marketing approval. Effective preparation commences with an inspection readiness assessment, followed by the development of a robust inspection plan, and culminates in the execution of a mock inspection. The latter mimics all preparatory measures and brings to light any deficiencies in activities or processes requiring remedial action.

In an inspection readiness assessment, study teams can harness AI insights to pinpoint areas of potential risk within their clinical trial processes, subsequently devising appropriate remedial measures. While sponsors bear the primary responsibility for overseeing all data and processes related to their trials, study teams can leverage AI tools to bolster their inspection readiness endeavors. Review three common inspection findings and ways to integrate AI into your inspection readiness strategy by accessing the full article below.