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 […]
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: Innovating Inspection Readiness and TMF Quality As your partner in clinical trials, we at Just in Time GCP understand the challenges of maintaining inspection readiness, especially regarding the quality and completeness of Trial Master Files (TMFs). With the integration of Generative AI into clinical trial management, we are dedicated to helping our clients […]
Ensuring Your Operations Support Your Trial’s Scope Moderating a recent roundtable discussion on clinical process assessment has highlighted a growing gap between current clinical process capabilities and the requirements needed to execute complex studies. A comprehensive assessment of clinical processes, systems, and infrastructure is essential to ensure they align with both regulatory requirements to ensure […]
The Importance of TMF Management in Clinical Quality Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her expertise in a recent article in The Clinical Trial Vanguard titled The Trial Master File: A Window into the Quality of Any Clinical Study. This article highlights the essential role of the Trial Master File (TMF) […]
