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.
Proactive GCP Compliance: Insurance for Your Clinical Trial In the world of clinical trials, compliance with Good Clinical Practice (GCP) is often seen as just another regulatory requirement—something to check off a list to satisfy inspectors. But in reality, proactive GCP compliance is much more than that; it’s like an insurance policy for both your […]
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 […]