Lessons from the 2025 CDISC US + TMF Interchange — By Kathleen Mellet, Business Analyst at Just in Time GCP and Project Manager for The CDISC 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 […]
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 CDISC TMF Standard (formerly known as the CDISC 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 […]
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 CDISC 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 CDISC TMF Reference Model has become the most widely recognized framework for organizing 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.
ICH E6(R3) Risk Management and Oversight: A Priority Update for Sponsors ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to prioritize process updates so their teams don’t waste time or miss critical risks. At Beyond Clinical Compliance, on September 9th in Philadelphia, Donna Dorozinsky addressed this challenge in […]
Why CTQs, Clinical Data, and TMF Oversight Matter More Than Ever in Risk-Based Review Under ICH E6(R3) For years, risk review meant one thing: checking documents in the Trial Master File (TMF). In practice, this meant asking questions such as: Have the right files been uploaded? Were they signed on time? Are they in the […]