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 trial management, focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes […]
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 […]
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, […]
