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 […]
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.
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 […]
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 […]
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 […]
Just in Time GCP celebrates 20 years in clinical trial compliance and 5 years on the Inc. 5000 list of fastest-growing private companies.
ICH E6(R3) Sponsor Oversight: What Clinical Compliance Teams Must Know With ICH E6(R3) taking effect, sponsor oversight is entering a new era. The updated guideline makes it clear: sponsors must move beyond passive documentation and adopt a proactive, risk-based model of oversight. This isn’t just a compliance requirement—it’s a fundamental shift in how trials are […]
Free Tools to Assess eTMF Health Practical, No-Cost Resources for TMF Oversight and Inspection Readiness Your Trial Master File (TMF) is more than a clinical record / document repository—it’s the official story of your study. And under the finalized ICH E6(R3) guideline, it must be managed with risk-proportionate oversight that extends beyond completeness to include […]