Clinical Compliance News and Updates


GCP Compliance Industry Updates and Insights

ICH E6(R3) Sponsor Oversight

ICH E6(R3) Sponsor Oversight: What Clinical Compliance Teams Must Know With ICH E6(R3) taking effect this July, clinical research sponsors face a new mandate: move

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Future-Ready Clinical Compliance

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

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Reclaiming Your Trial Master File (TMF)

Reclaiming Your Trial Master File: A Strategic Move Toward Stronger Clinical Compliance As clinical trial complexity grows and regulatory expectations continue to evolve—particularly with the

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Risk-Based Quality Management

Implementing Risk-Based Quality Management Insights from the Latest GCP Guide Explore the 2024/2025 Edition of Barnett’s GCP Q&A Reference Guide The 2024/2025 edition of Barnett’s

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TMF Trends from 2024

Clinical Trial Master File Trends from 2024  As we approach 2025, the Clinical Trial Master File (TMF) landscape is undergoing substantial transformations driven by technological

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Generative AI

Generative AI: Innovating Inspection Readiness and TMF Quality   As your partner in clinical trials, we at Just in Time GCP understand the challenges of maintaining

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Clinical Process Assessment

Ensuring Your Operations Support Your Trial’s Scope Moderating a recent roundtable discussion on clinical process assessment has highlighted a growing gap between current clinical process

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Insights on TMF Management

The Importance of TMF Management in Clinical Quality Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her expertise in a recent article in

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