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I noted a compliance concern about two years ago with our trial master files and looked around the industry for help. Just in Time GCP was recommended as a specialist in fixing TMF compliance issues. Over the last two years working with the team, we formulated a plan for migrating and transferring our TMF’s into one system and now we have validated and updated this system. Together, we created TMF maps, plans, process and training. Donna and her team fit into our company. They worked tirelessly and as a result, we sailed through our last Health Authority inspection.

Just in Time was instrumental in helping us achieve two successful mock FDA inspections. The team came helped us perform a gap analysis on our study TMFs, created storyboards, and prepped all SMEs. They even audited sites. Every detail was covered - even down to which conference rooms we would use for inspection day and how many reams of paper we would need to have on hand.

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Risk-Based Quality Management

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. 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 E6(R3). Authored

Driving Growth at Just in Time GCP

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 help scale our success and meet increasing demand. For over twenty years, Just in Time GCP has empowered our partners with clinical compliance confidence. By aligning people, processes, and technologies with Good Clinical Practices and

The CDISC TMF Reference Model at Small Companies

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). The CDISC TMF Reference Model (TMF RM) provides a best-practice blueprint for structuring and managing your TMF to meet regulatory and clinical compliance standards. The TMF Reference Model is maintained by a Steering Committee of

ICH E6(R3) Release – Aligning Clinical Processes

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 trial management, focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes principles, its implementation requires sponsors to translate these into actionable business process updates. Below, we outline practical examples of how sponsor organizations now need to adapt their processes to align with ICH E6 (R3).

Hidden TMF Clinical Compliance Risks

Hidden TMF Clinical Compliance Risks Inspectable Content Housed OUTSIDE the TMF In the fast-paced world of clinical trials, maintaining a robust and compliant Trial Master File (TMF) is essential for inspection readiness. Yet, many sponsors inadvertently overlook critical TMF content that they generate during the trial, only to scramble for it during preparation for regulatory inspections or asset transfers. This oversight can create unnecessary stress and risk for organizations. The TMF is defined as the collection of records that show that the trial is being conducted to regulatory requirements. This

20 Years of Clinical Compliance Excellence

20 Years of Delivering Clinical Compliance Confidence Founded in 2005, Just in Time GCP has empowered our partners with clinical compliance confidence for over 20 years. We align people, processes, and technologies with Good Clinical Practices (GCP) and your unique organizational goals, enhancing study success and providing you with peace of mind. Simplify GCP Compliance, Amplify Clinical Success Our team of over 100 full-time clinical experts offers comprehensive GCP compliance support, including: Upcoming inspection assistance System implementation solutions SOP creation Clinical oversight Asset acquisition Ongoing support Immediate remediations Quick quality