This collection explores how fit-for-purpose technology and innovation support clinical compliance and inspection readiness. Articles focus on the practical application of digital systems and emerging tools to strengthen oversight, improve data confidence, and enable risk-based approaches within regulated clinical environments.
Let’s Stop Talking About AI. Let’s Actually Use It. Why innovation-ready sponsors are moving beyond AI theory, and why Just in Time GCP’s approach is different. Over the last two years, AI has dominated the clinical research conversation. We’ve all heard the promises: faster filing, cleaner TMFs, automated QC, and real-time insights. But for all the discussion, very little […]
What EMA’s New AI and Data Integrity Guidelines Signal for Clinical Research In July 2025, the European Commission opened a public consultation on updates to EudraLex Volume 4, with revisions developed by the EMA GMDP Inspectors Working Group, in cooperation with PIC/S. The consultation covers three documents: Chapter 4 – Documentation Annex 11 – Computerized […]
Just in Time GCP – AI Accountability Charter Innovation with purpose. Compliance with confidence. When it comes to AI, not all solutions are created equal. That’s why our approach is grounded in over 20 years of clinical compliance expertise and aligned with ICH E6(R3), the EU AI Act, and FDA expectations for trustworthy, transparent AI. Together, […]
The Next Era of TMF: Strategic Planning for the Digitization of the CDISC TMF Standard (formerly known as the CDISC TMF Reference Model) The Trial Master File (TMF) is entering a new era. As clinical research becomes more digital, decentralized, and data-driven, the way we structure and manage essential trial records must evolve too. That […]
Managing site personnel documentation is one of the most time-consuming and error-prone tasks in TMF oversight. Learn how we’ve trained our AI to help and see the results.
Just in Time GCP Expands Innovation Team to Advance AI in Clinical Compliance At Just in Time GCP, innovation is treated as more than a concept. It is how sponsors are supported in achieving clinical compliance, TMF oversight, and inspection readiness with confidence. As trials grow more complex and expectations rise, new people and technology […]
Falling Behind: The Consequences of Ignoring Innovation in Clinical Compliance In an era where technology is evolving at lightning speed, innovation in clinical compliance innovation is no longer optional — it’s essential. Tools like artificial intelligence (AI), machine learning (ML), and intelligent automation are rapidly transforming how we manage compliance activities, oversee the Trial Master […]
AI and other next-generation technologies are poised to reshape clinical research as we know it—especially in how we manage clinical data, operations, and compliance. What’s coming isn’t just incremental improvement—it’s transformational. From automated Trial Master File (TMF) oversight to intelligent quality monitoring, these innovations will streamline operations, reduce risk, and elevate compliance to a level that simply isn’t possible with manual processes.
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 […]
Generative AI in Clinical Trials At Just in Time GCP, we know the pressure trial sponsors face to stay inspection-ready while managing the quality and completeness of the Trial Master File (TMF). Generative AI is opening new opportunities to address these challenges—helping sponsors balance speed, cost, and compliance while strengthening TMF integrity. Understanding the Challenges […]