These articles examine sponsor oversight models and operational practices that support effective execution of clinical trials. Topics include sponsor-CRO oversight, governance structures, escalation pathways, and operational accountability, with an emphasis on aligning day-to-day execution with regulatory and quality expectations.
This New Year, Don’t Hope for Change… Manage It! by Meghan O’Brien (Zuchlewski), Operations & Change Lead, Just in Time GCP Each January, we start fresh with new goals, new priorities, and new plans. We promise ourselves that this year will be different. But by February, nearly 80% of resolutions have faded. Not because people don’t want to change, but because wanting isn’t managing. Change, whether personal or professional, […]
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 […]
Change Management Preparing, Managing, and Sustaining Organizational Change Change is inevitable, especially in today’s fast-paced and dynamic world. Whether it’s implementing new technology or restructuring processes, organizations must effectively manage change to thrive and remain competitive. However, change can be disruptive and challenging to navigate without a clear strategy in place. This is where change […]