Lessons from recent clinical inspections, sponsor oversight obligations, and best practices to ensure your trial documentation stands up to regulatory review. Maintain a continual state of inspection readiness.
Rethinking “State of Control” in a Cloud-Driven Clinical Environment Why Annex 11 Matters for eTMF — Even Outside GMP By Kathie Clark, Industry Expert; Technology & Innovation Partner, Just in Time GCP The new draft of EMA’s Annex 11 of the EU GMP guidelines governs computerized systems used in manufacturing environments. However, its principles—lifecycle validation, […]
GCP Was Built on GMP: Why Clinical Teams Need to Understand Their Shared DNA A Shared History Many Clinical Professionals Never Learn Good Manufacturing Practices (GMP) came decades before Good Clinical Practice (GCP). When regulators began shaping GCP in the 1970s–1990s, they did not build a new quality system from scratch. Instead, they extended the […]
FDA Warning Letters aren’t just regulatory formalities—they’re red flags signaling oversight gaps that can jeopardize patient safety, trial integrity, and sponsor credibility.
Free Tools to Assess eTMF Health Practical, No-Cost Resources for TMF Oversight and Inspection Readiness Your Trial Master File (TMF) is more than a clinical record / document repository—it’s the official story of your study. And under the finalized ICH E6(R3) guideline, it must be managed with risk-proportionate oversight that extends beyond completeness to include […]
Change Management in Clinical Research—Turn Disruption into Progress New technologies, revised SOPs, and updated regulatory frameworks like ICH E6(R3)—in clinical research, change is a constant. When managed poorly, that change can compromise timelines, compliance, and overall study quality. That’s why effective change management in clinical research is no longer optional—it’s essential. At Just in Time […]
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 […]