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 […]
Just in Time GCP to Present at CDISC + TMF Europe Interchange 2025 We’re excited to announce that Just in Time GCP will be participating in the CDISC + TMF Europe Interchange, taking place May 14–15, 2025 in Geneva, Switzerland. As an Emerald Sponsor, we’re proud to join global leaders in discussing the evolution of […]
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 […]
Tina Henderson Joins Just in Time GCP to Lead Life Sciences Consulting Just in Time GCP continues to grow, and we are excited to welcome Tina Henderson, RN, MBA, MS, CCRA, CCRC, as the new Head of Life Sciences Consulting. With over 25 years of experience in the industry, Tina leads transformative initiatives that align […]
Implementing Risk-Based Quality Management Insights from the Latest GCP Guide Explore the 2024/2025 Edition of Barnett’s GCP Q&A Reference Guide The 2024/2025 edition of Barnett’s Good Clinical Practice (GCP) A Question & Answer Reference Guide is a must-have resource for clinical compliance professionals. With over 500 pages of expert insights and more than 1,500 questions […]
George Lyon Joins Just in Time GCP to Drive Commercial Growth Just in Time GCP is experiencing rapid expansion, and to sustain our momentum, we welcome George Lyon as our Chief Commercial Officer. With over 30 years of experience in strategic sales, team building, and commercial transformation, Lyon steps in at a crucial time to […]
Why the CDISC TMF Reference Model is Important for Smaller Companies Executing Clinical Trials If you’re a small or emerging life sciences company, navigating the complexities of clinical trials can be daunting. A key element to understand is the Trial Master File (TMF)—a collection of essential records that ensure compliance with Good Clinical Practice (GCP). […]
ICH E6(R3) Finalization – An Action Plan for Clinical Compliance Critical Impacts of ICH E6 (R3) and Business Process Updates for Clinical Trial Sponsors The release of ICH E6 (R3) ushers in a new era of clinical compliance focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes familiar […]
Hidden TMF Clinical Compliance Risks The Risk Of Inspectable Content Housed Outside the TMF In the fast-paced world of clinical trial compliance, maintaining a robust and compliant Trial Master File (TMF) is essential for inspection readiness clinical trials. Yet, many sponsors inadvertently overlook critical good clinical practice (GCP) documentation. This oversight can create unnecessary stress […]
20 Years of Clinical Compliance Confidence — And Counting Since 2005, Just in Time GCP has been helping clinical trial teams move forward with clarity, control, and confidence. Now, as we celebrate two decades of service, we stand proudly as one of the most established and experienced partners in clinical research compliance. In an industry […]