The TMF Reference Model Is Becoming a Standard: What That Means for TMF Teams For many TMF teams, the TMF Reference Model is still the language of daily work. It shaped how TMFs were structured, how records were categorized, and how teams aligned internally and with partners. That foundation remains important, but it is evolving. The TMF […]
FDA’s Guiding Principles of Good AI Practice: Is Your Vendor in Compliance? By Kathie Clark, Industry Expert; Technology & Innovation Partner, Just in Time GCP As artificial intelligence becomes increasingly embedded in drug development and clinical operations, regulators are making one thing clear: AI cannot be evaluated like traditional software. In January 2026, the FDA and […]
How Does AI Fit Into Your Clinical Oversight Model? Connecting at SCOPE If you’re attending SCOPE Summit, this is a conversation worth having now, not later. How does AI actually fit into your clinical oversight model? That’s the question many trial sponsors are quietly asking right now, as AI moves from concept to day-to-day use, and assumptions give way to accountability. The shift […]
Helping Small Biopharma Thrive With Agile Trials and Smarter Data | SCOPE Summit 2026 Clinical trials are not just getting bigger; they are becoming more interconnected. As a result, sponsors are managing: More vendors, often across multiple functional areas More systems, each with its own data structures and dependencies More handoffs, where accountability can become […]
Why Clinical Study Data Flow Maps Are Becoming an Inspection Conversation Clinical trial data has never been more distributed. Today’s studies generate data at sites, through participants, from devices, and across a growing network of vendors and platforms. As a result, trial sponsors are increasingly asked not only where their data resides, but how it moves, […]
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 […]
This New Year, Don’t Hope for Change… Manage It! by Meghan O’Brien (Zuchlewski), Operations & Change Lead, Just in Time GCP Each January, we start fresh with new goals, new priorities, and new plans. We promise ourselves that this year will be different. But by February, nearly 80% of resolutions have faded. Not because people don’t want to change, but because wanting isn’t managing. Change, whether personal or professional, […]
Are You Ready for a CNPV Inspection on Day One? How Sponsors Can Stay Ahead When Speed Meets Scrutiny The FDA’s new Commissioner’s National Priority Voucher (CNPV) program is redefining what “fast-tracked” really means. For the first time, sponsors developing therapies that address urgent national priorities such as major public health crises, domestic manufacturing gaps, or critical […]
Rethinking “State of Control” in a Cloud-Driven Clinical Environment Why Annex 11 Matters for eTMF — Even Outside GMP By Kathie Clark, Industry Expert; Technology & Innovation Partner, Just in Time GCP The new draft of EMA’s Annex 11 of the EU GMP guidelines governs computerized systems used in manufacturing environments. However, its principles—lifecycle validation, […]
GCP Was Built on GMP: Why Clinical Teams Need to Understand Their Shared DNA A Shared History Many Clinical Professionals Never Learn Good Manufacturing Practices (GMP) came decades before Good Clinical Practice (GCP). When regulators began shaping GCP in the 1970s–1990s, they did not build a new quality system from scratch. Instead, they extended the […]