Just in Time GCP’s Core Values The Principles That Guide How We Work At Just in Time GCP, we believe the way work gets done matters just as much as the outcome. As our team has grown and evolved, we took time to reflect on the principles that shape how we work together, support our […]
FDA, MHRA, and Health Canada Signal a Growing Focus on Data Governance and Data Flows What Trial Sponsors Should Know About Clinical Study Data Flow Maps Under ICH E6(R3) At the start of June, during the 5th FDA-MHRA-Health Canada Symposium on Regulatory Perspectives in Good Clinical Practice, Bioequivalence & Good PV Practice, the FDA Lead for ICH E6(R3), described one […]
Top TMF Metrics Every Clinical Trial Should Monitor in 2026 As clinical trials become increasingly complex, sponsors face growing pressure to demonstrate oversight, maintain contemporaneous documentation, and support clinical inspection readiness throughout the study lifecycle. For years, Trial Master File (TMF) programs have focused heavily on completeness, timeliness, and quality. These metrics remain essential. However, today’s clinical trial environment demands a broader […]
TMF Standard Model V1: Key Updates from CDISC Europe and What Clinical Teams Should Know Clinical trials are becoming more digital, more system-dependent, and more complex. At the same time, clinical teams are managing growing volumes of trial evidence across sponsors, service providers, systems, and repositories. That matters because the Trial Master File (TMF) is more than […]
Just in Time GCP Certified as Veeva Basics Services Partner Just in Time GCP has been a trusted Services Partner of Veeva Systems for several years, supporting clients across the Veeva Development Cloud. We are pleased to share that we have now been certified as a Veeva Basics Services Partner, expanding our ability to support organizations executing Veeva […]
RTCT May Redefine What Operational Oversight Looks Like Signals, latency, interoperability, and the future of operational oversight and inspection readiness This article reflects insights and analysis following the FDA Industry Information Session on Real-Time Clinical Trials held on May 15, 2026 from 11:00 AM – 1:00 PM ET. Participants: Jeremy Walsh, Chief AI Officer, FDA Malika Mundkur, […]
What Proactive Quality Oversight Looks Like in the ICH E6(R3) Era Reflections Ahead of the SQA Annual Meeting ICH E6(R3) reinforces something clinical quality leaders have long understood: oversight cannot be reactive. Sponsors are expected to demonstrate that risks are identified early, controls are implemented deliberately, and systems operate in a way that protects data […]
From Principle to Practice: Applying the FDA and EMA AI Guiding Principles in Clinical Trials How Just in Time GCP Operationalizes the FDA and EMA Guiding Principles for Good AI Practice By Kathie Clark, Industry Expert; Technology & Innovation Partner, Just in Time GCP As AI-enabled tools are increasingly adopted across clinical operations, Life Science […]
The TMF Reference Model Is Becoming a Standard: What That Means for TMF Teams For many TMF teams, the TMF Reference Model is still the language of daily work. It shaped how TMFs were structured, how records were categorized, and how teams aligned internally and with partners. That foundation remains important, but it is evolving. The TMF […]
Reclaiming Your Trial Master File: A Strategic Move Toward Stronger Clinical Compliance As clinical trial complexity grows and regulatory expectations continue to evolve—particularly with the release of ICH E6(R3)—more sponsors are rethinking how their Trial Master File (TMF) is managed. While Contract Research Organizations (CROs) remain essential partners in trial execution, many organizations are choosing […]