This collection addresses how trial sponsors prepare for and demonstrate GCP readiness under real inspection conditions. The articles reflect common inspection focus areas, emerging risk signals, and practical approaches to maintaining confidence in oversight, documentation, and decision-making before, during, and after clinical inspections.
How Generative AI is Transforming GCP Inspection Readiness Just in Time GCP’s Founder and CEO, Donna Dorozinsky, contributed a guest column for Clinical Leader outlining the impact of generative AI on GCP inspection and clinical trial readiness. She describes its transformative potential and how sponsors can prepare today for adoption and integration of AI- driven […]
