Risk-Based Monitoring for Clinical Trial Sites – Keys to Successful Implementation
In an effort to start quality and risk mitigation initiatives early in the clinical development process, the US Food and Drug Administration (FDA) issued the “Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring.” Shortly thereafter, the European Medicines Agency (EMA) released the “Reflection Paper on Risk Based Quality Management in Clinical Trials.” Industry has largely embraced quality risk management (QRM) as a way to ensure success and profitability. However, there is still some confusion as to how to implement these concepts.
Key to the success of QRM is the capacity to leverage existing information in such a way that stakeholders can easily assess whether the processes they are responsible for will yield the intended results and quality. This approach helps organizations to proactively identify, manage, and mitigate risks before they manifest into real problems. A risk-based approach requires not only a strategy, but tools to define indicators that measure specific risks. As referenced in the recent FDA and EMA guidances, Key Risk Indicators (KRIs) should focus on “what really matters” with an emphasis on patient safety and data integrity, and be tied to particular processes within the clinical drug development spectrum. This seminar will provide you with a strong foundation for identifying and managing important risks to quality in managing clinical trial sites with a focus on risk-based monitoring.
Attend this 90-minute interactive session, and you will learn to:
- Define a Quality Risk Management system (QRM)
- Describe QRM as a transformational philosophy and process to detect, prioritize, manage, and resolve risks at the site level
- Elevate/confirm awareness of site risks to clinical trial patient safety and data integrity
- Apply QRM principles: Identification and quantification of key risk indicators
- Leverage existing information to support decision making in resource allocation within clinical trials (risk-based monitoring)
- Create a governance model to support mitigation strategies and implement a QRM infrastructure
This interactive online course will be highly beneficial to anyone in clinical development and/or clinical research. Those with responsibilities that include trial site management/monitoring – and ensuring trial quality – will find this training particularly useful.
Kenneth Schiff, mMBA, BA is the president/owner of Quality Risk Management Associates, LLC, a consulting firm which specializes in providing risk management support to pharmaceutical and biotechnology companies around the world. With broad expertise in all phases of pharmaceutical development, Quality Risk Management Associates ensures regulatory compliance and minimizes risk across the clinical development process. They have successfully transformed traditional quality assurance methods by spearheading innovative quality risk management and compliance systems and driving new governance and control standards that help business partners proactively identify, manage, and mitigate risk.
Prior to this, Ken joined Hoffmann LaRoche/Genentech in 2006 as the Head of Quality Assurance and Quality Risk Management based in Nutley, NJ USA. He was responsible for overseeing quality assurance support and applying quality risk management concepts in the conduct of clinical trials. He started his career in the pharmaceutical industry in Clinical Quality Assurance at Merck & Co. Inc. in 1990.
Ken has also been an active member of the Clinical Trial Transformation Initiative working closely with the FDA on the BIMO Modernization and Critical Path Initiatives, with specific focus on Quality Risk Management concepts. Mr. Schiff obtained his BA degree in Biological Sciences/Pre-Medicine and MBA Certificate in Biopharma Innovation & Entrepreneurship from Rutgers University.