mindsON RBQM Workshop | Episode 37: Why is setting thresholds so tricky?

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Moderators

MyRBQM Academy by Cyntegrity

Targeted education helps clinical research teams embrace the implementation process and contribute to its success, ensuring your organization's RBQM strategy has the components it needs to meet regulatory expectations.

Established in 2019, Cyntegrity's MyRBQM® Academy, units first-level online education, comprehensive instructor-led training, and practical case study workshops. Learn more at: www.academy.cyntegrity.com

Dr. Johann Proeve

Johann has over 45 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.

Keith Dorricott, MBB

Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the Avoca Quality Consortium, such as Centralized Monitoring, eCOA, and Vendor Oversight.

June 26, 2024 Michal Helbin

A comprehensive approach to the management of risks in a clinical study. The platform is very well designed, it has been very well presented during the webinar. The platform is detailed but graphically appealing. It utilizes the smart risk categories as proposed by the TransCelerate Biopharma, uses some proprietary tools and knowledge as designed by the Cyntegrity and is easily scalable should any organization need to add more categories at any time. Its a product well done.

October 22, 2025 Naomi Bossman

I appreciate the expertise and interpersonal dynamic of the presenters/moderator, as well as, examples, lessons learned, exercises, and ability to learn from other's experiences. Big fan of Cyntegrity! Thank you for hosting these webinars.

November 12, 2025 Mary Banach

Thank you - This webinar was exactly what is needed in the CDM Community. Mary Banach Chair DIA CDM Community

Description

Have you come across KRI thresholds that are constant, or variable, or relative? How easy is it to use historic data to set them? Can they be changed during the trial? Are there any additional considerations for QTLs and Acceptable Ranges? Join our experts, Keith and Johann, as they discuss these questions. Come along to share your views via polling and whiteboards or just to listen and learn.

ABOUT "mindsON RBQM" WORKSHOPS

The mindsON RBQM workshops provide practical, system-agnostic guidance on the challenges of implementing and executing Risk-Based Quality Management (RBQM) in day-to-day clinical trial operations. These sessions emphasize interactive dialogue and problem-solving, offering a collaborative space to share experiences, explore strategies, and tackle real-world challenges.

Rooted in Quality by Design (QbD) principles, mindsON RBQM focuses on concepts and strategies without being tied to any specific system. For those looking to see these principles applied through technology, the actON QbD series offers complementary workshops with live demonstrations of use cases powered by the MyRBQM Portal.

Whether you choose to participate or simply observe actively, mindsON RBQM provides the knowledge and tools you need to navigate RBQM implementation confidently and effectively.