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 clinical compliance insights, but it’s no coincidence that this reflection reaffirmed how closely our company’s core principles align with many of the industry themes presented at the event. Here’s the formula that continues to resonate

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 to take a more active role in TMF oversight by reclaiming ownership internally. This shift isn’t about replacing CROs—it’s a strategic move toward greater visibility, improved inspection readiness, and stronger clinical compliance. Sponsors who take

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 clinical compliance, TMF best practices, and the future of trial documentation. Our team will be featured in two sessions: Trial Master File (TMF) Track PresentationHow to Leverage Next-Generation Tools TODAY to Optimize TMF Processing and

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 clinical trial and your asset. You can either invest in it upfront—establishing the right processes, systems, and documentation—or take shortcuts and risk facing costly, potentially devastating consequences down the road. Read more on Four Reasons

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 business objectives with execution. Her expertise in scalable infrastructure and clinical operations optimization makes her a perfect fit for Just in Time GCP’s consulting solutions. Tina’s career journey reflects a broad, in-depth understanding of clinical

Implementing Risk-Based Quality Management: Insights from the Latest GCP Guide The 2024/2025 edition of Barnett’s Good Clinical Practice (GCP) A Question & Answer Reference Guide is a comprehensive resource on clinical compliance, featuring over 500 pages of expert insights and answering 1,500+ questions related to GCP and regulatory expectations. Part of this latest edition, edited by Donna Dorozinsky, CEO & Founder of Just in Time GCP, includes a dedicated chapter on Risk-Based Quality Management (RBQM)—a critical addition in light of the evolving clinical trial landscape and the finalization of ICH