Just in Time GCP

GCP Directions – Simplifying Clinical Compliance

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 […]

AI in Clinical Compliance

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 […]

Veeva R&D Quality Summit 2025

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 […]

ICH E6(R3) Sponsor Oversight

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 […]

Trial Master File Health Assessment

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 […]

When Drugs Fail: Is it Bad Science—or Just Bad Research?

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

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 […]

Why Innovation in Clinical Compliance Can’t Wait

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 […]