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 […]
How Generative AI is Transforming GCP Inspection Readiness Just in Time GCP’s Founder and CEO, Donna Dorozinsky, contributed a guest column for Clinical Leader outlining the impact of generative AI on GCP inspection and clinical trial readiness. She describes its transformative potential and how sponsors can prepare today for adoption and integration of AI- driven […]
Clinical Trial Master File Trends from 2024 As we approach 2025, the Clinical Trial Master File (TMF) landscape is undergoing substantial transformations driven by technological advancements and evolving regulatory requirements. At Just in Time GCP, we work with TMFs of all shapes and sizes, and this year, we have identified several clear trends that will […]
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 […]
