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, […]
Pondering The “What Ifs” Of Inspection Readiness with Generative AI 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 readiness. She describes it’s transformative potential and how to prepare your clinical trials today for adoption and integration. Key Highlights […]
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 […]
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) […]
Just In Time GCP: Recognized for Impact and Innovation in Clinical Research Just In Time GCP is excited to announce our recognition as #9 on the Philadelphia Business Journal’s 2024 Largest Women-Owned Businesses in Greater Philadelphia. This prestigious accolade underscores our commitment to excellence and innovation within the clinical research industry. Additionally, we are thrilled […]
