ICH E6(R3) Sponsor Oversight: What Clinical Compliance Teams Must Know With ICH E6(R3) taking effect this July, clinical research sponsors face a new mandate: move beyond passive documentation and adopt a more proactive, risk-based approach to oversight. The latest guidance signals a shift—sponsor oversight must be continuous, data-driven, and directly linked to risk management and […]
Future-Ready Clinical Compliance Start the Conversation About Innovation Now AI and other next-generation technologies are poised to reshape clinical research as we know it—especially in how we manage clinical data, operations, and compliance. What’s coming isn’t just incremental improvement—it’s transformational. From automated Trial Master File (TMF) oversight to intelligent quality monitoring, these innovations will streamline […]
Innovation, Data & Collaboration—The Formula for Progress in Clinical Compliance Authored by Al Pacheco, Director, Business & Technology Consulting, Just in Time GCP I was fortunate to take some time—thanks to my team at Just in Time GCP—to reflect on key takeaways from this year’s SCOPE conference in Orlando, Florida. What follows are my personal […]
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). […]
