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 growing rapidly. To sustain this momentum, we welcome George Lyon as our Chief Commercial Officer. Lyon brings 30+ years of experience in strategic sales, team building, and commercial transformation. He joins us at a crucial time to scale success […]
Just Announced October 13, 2025 – Read More Here Why the TMF Standard 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 […]
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 Excellence — 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 where […]
Just in Time GCP Welcomes George Lyon as Chief Commercial Officer Just in Time GCP is excited to announce the appointment of George Lyon as our new Chief Commercial Officer. “Excited to welcome George Lyon as Chief Commercial Officer at Just in Time GCP! George brings a wealth of expertise in business development and […]
Generative AI in Clinical Trials At Just in Time GCP, we know the pressure trial sponsors face to stay inspection-ready while managing the quality and completeness of the Trial Master File (TMF). Generative AI is opening new opportunities to address these challenges—helping sponsors balance speed, cost, and compliance while strengthening TMF integrity. Understanding the Challenges […]
Clinical Process Assessment: Aligning Operations with Trial Scope and GCP Compliance A recent roundtable on clinical process assessment revealed a growing gap between current clinical operations and the capabilities needed to run today’s complex studies. Conducting a comprehensive review of processes, systems, and infrastructure ensures alignment with regulatory requirements, compliance expectations, and available resources. A […]
TMF Management in Clinical Trials: Ensuring Quality, Compliance, and Oversight Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her insights in The Clinical Trial Vanguard article titled The Trial Master File: A Window into the Quality of Any Clinical Study. The article underscores the TMF’s essential role in maintaining compliance, oversight, and data […]