These articles capture insights and emerging signals from industry conferences, panels, and peer discussions. They reflect how clinical oversight, quality expectations, and sponsor responsibilities are evolving, informed by dialogue across the clinical research ecosystem.
Lessons from the 2025 CDISC US + TMF Interchange — By Kathleen Mellet, Business Analyst at Just in Time GCP and Project Manager for The CDISC TMF Standard Model How the TMF Community Is Shaping the Next Era of Standardization At this year’s CDISC US Interchange in Nashville, the Trial Master File (TMF) community came […]
ICH E6(R3) Clinical Data Integrity & Technology Governance: A Priority Update for Sponsors ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to strengthen how they govern data and technology so their teams can maintain control across complex, multi-vendor environments. At Beyond Clinical Compliance on September 9 in Philadelphia, Donna […]
Key Takeaways from the Inaugural Beyond Clinical Compliance Conference I recently attended the Beyond Clinical Compliance conference in Philadelphia, hosted by KH Conferences. The presentations and conversations offered clear insight into where the industry is headed, especially around ICH E6(R3) adoption, risk management, data integrity, quality culture, and GCP inspection readiness. ICH E6(R3) The industry […]
ICH E6(R3) Risk Management and Oversight: A Priority Update for Sponsors ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to prioritize process updates so their teams don’t waste time or miss critical risks. At Beyond Clinical Compliance, on September 9th in Philadelphia, Donna Dorozinsky addressed this challenge in […]
Why CTQs, Clinical Data, and TMF Oversight Matter More Than Ever in Risk-Based Review Under ICH E6(R3) For years, risk review meant one thing: checking documents in the Trial Master File (TMF). In practice, this meant asking questions such as: Have the right files been uploaded? Were they signed on time? Are they in the […]
GCP Directions: Virtual Engagement for Clinical Compliance and Quality Professionals GCP Directions—the leading clinical compliance and quality conference—returns in July 2026. The 2025 event brought together senior clinical research, compliance, and quality professionals from across the industry for three days of virtual learning, networking, and forward-looking conversations. Designed specifically for trial sponsors, GCP Directions delivered […]
Just in Time GCP Spotlight: Veeva R&D and Quality Summit 2025 The Just in Time GCP team attended the Veeva R&D Quality Summit in Boston, where we proudly served as a Gold Sponsor. The Summit was an exciting experience. It offered a chance to engage with Veeva experts, partners, and users, and to see innovations […]
Why Just in Time GCP is Proud to Join the 2025 Veeva R&D Quality Summit In just a few weeks, the Just in Time GCP team will be in Boston for the Veeva R&D Quality Summit, where we are proud to once again serve as a Gold Sponsor. This event is one of the most […]
Innovation, Data & Collaboration—The Formula for Progress in Clinical Compliance Authored by Al Pacheco, Director, Business & Technology Consulting, Just in Time GCP I was fortunate to take some time—thanks to my team at Just in Time GCP—to reflect on key takeaways from this year’s SCOPE conference in Orlando, Florida. What follows are my personal […]
Just in Time GCP to Present at CDISC + TMF Europe Interchange 2025 We’re excited to announce that Just in Time GCP will be participating in the CDISC + TMF Europe Interchange, taking place May 14–15, 2025 in Geneva, Switzerland. As an Emerald Sponsor, we’re proud to join global leaders in discussing the evolution of […]