Insights on operational excellence in clinical trials, including change management, training, resource planning, and quality culture. Explore strategies to strengthen day-to-day execution while supporting compliance.
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 […]
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 Good Clinical Practice (GCP) A Question & Answer Reference Guide is a must-have resource for clinical compliance professionals. With over 500 pages of expert insights and more than 1,500 questions […]
ICH E6(R3) Finalization – An Action Plan for Clinical Compliance Critical Impacts of ICH E6 (R3) and Business Process Updates for Clinical Trial Sponsors The release of ICH E6 (R3) ushers in a new era of clinical compliance focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes familiar […]
Clinical Process Assessment: Aligning Operations with Trial Scope and GCP Compliance A recent roundtable on clinical process assessment revealed a growing gap between current clinical operations and the capabilities needed to run today’s complex studies. Conducting a comprehensive review of processes, systems, and infrastructure ensures alignment with regulatory requirements, compliance expectations, and available resources. A […]