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 Understanding Generative AI: An overview of the capabilities and benefits of generative AI in regulatory inspections. Navigating Complexities: Insights into the challenges organizations face in adopting this technology. Strategic Implementation: Best practices for integrating AI

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 significantly impact TMF management.  Increased Adoption of Electronic TMF (eTMF) Systems  The transition to electronic TMF (eTMF) systems is gaining traction, driven by several key developments:  Cloud-Based Solutions: An increasing number of clinical trials are

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 strategic growth, and his leadership will be instrumental as we expand our footprint in the industry. With George at the helm of our commercial strategy, we’re poised to forge new partnerships, drive innovation, and deliver

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 harness innovation to navigate these complexities.  The upcoming digitized Version 4 of the CDISC TMF Reference Model is a significant advancement in this area. Our JiT team members, including Donna Dorozinsky, Aaron Grant, and Kathleen

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 compliance and resourcing structures/limitations. This type of evaluation provides trial sponsors with vital insights to standardize a proactive approach GCP compliance by optimizing procedures. What Could Happen if There Is Misalignment? Compromised Data Integrity Regulatory

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) in ensuring the quality, compliance, and integrity of clinical trials. Key Insights on Study Quality from TMF In the article, Donna discusses several critical aspects of the TMF and the potential quality implications if they