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 […]
The hidden cost of poor research quality in clinical trials Not every drug will make it through development. Some will fail for scientific reasons—mechanisms that don’t work, safety issues, biological complexities we can’t always predict. But when a clinical trial failure from poor research occurs, it’s a different kind of loss. That’s not science failing. […]
Change Management in Clinical Research—Turn Disruption into Progress New technologies, revised SOPs, and updated regulatory frameworks like ICH E6(R3)—in clinical research, change is a constant. When managed poorly, that change can compromise timelines, compliance, and overall study quality. That’s why effective change management in clinical research is no longer optional—it’s essential. At Just in Time […]
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 […]
Future-Ready Clinical Compliance Start the Conversation About Innovation Now 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 […]
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 […]