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 […]
What EMA’s New AI and Data Integrity Guidelines Signal for Clinical Research In July 2025, the European Commission opened a public consultation on updates to EudraLex Volume 4, with revisions developed by the EMA GMDP Inspectors Working Group, in cooperation with PIC/S. The consultation covers three documents: Chapter 4 – Documentation Annex 11 – Computerized […]
Lessons from the 2025 CDISC US + TMF Interchange — By Kathleen Mellet, Business Analyst at Just in Time GCP and Project Manager for The TMF Standard Model How the TMF Community Is Shaping the Next Era of Standardization At this year’s CDISC US Interchange in Nashville, the Trial Master File (TMF) community came together […]
ICH E6(R3) Clinical Data Integrity & Technology Governance: A Priority Update for Sponsors ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to strengthen how they govern data and technology so their teams can maintain control across complex, multi-vendor environments. At Beyond Clinical Compliance on September 9 in Philadelphia, Donna […]
Just in Time GCP – AI Accountability Charter Innovation with purpose. Compliance with confidence. When it comes to AI, not all solutions are created equal. That’s why our approach is grounded in over 20 years of clinical compliance expertise and aligned with ICH E6(R3), the EU AI Act, and FDA expectations for trustworthy, transparent AI. Together, […]
Leading with Vision: How Donna Dorozinsky Balances Innovation and Integrity in Clinical Research Compliance In an era where clinical trials are becoming more complex and data-rich than ever before, true leadership requires both courage and clarity. At Just in Time GCP, Founder and CEO Donna Dorozinsky leads with both vision and discipline—driving innovation while ensuring […]
The Next Era of TMF: Strategic Planning for the Digitization of the TMF Standard (formerly known as the TMF Reference Model) The Trial Master File (TMF) is entering a new era. As clinical research becomes more digital, decentralized, and data-driven, the way we structure and manage essential trial records must evolve too. That evolution reached […]
Key Takeaways from the Inaugural Beyond Clinical Compliance Conference I recently attended the Beyond Clinical Compliance conference in Philadelphia, hosted by KH Conferences. The presentations and conversations offered clear insight into where the industry is headed, especially around ICH E6(R3) adoption, risk management, data integrity, quality culture, and GCP inspection readiness. ICH E6(R3) The industry […]
Announced on October 13, 2025 – Learn More Here Does Everyone Use the TMF Reference Model? The short answer: no — not everyone uses it. But nearly every sponsor, CRO, and vendor in clinical research is influenced by it. The TMF Reference Model has become the most widely recognized framework for organizing the Trial Master […]
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.