actON QbD | Episode 10: How do you keep QbD/RBQM on track during the trial?

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Registration for the webinar

Currently there are no future dates for the webinar.

Moderators

Moderator 1 of the webinar: MyRBQM Academy by Cyntegrity

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

Moderator 2 of the webinar: <p>Julien Goncalves<br>Head of Growth<br>(Cyntegrity)</p>

Julien Goncalves
Head of Growth
(Cyntegrity)

Julien brings years of pre-clinical and clinical research expertise to his strategic leadership role. A dynamic speaker and masterful demonstrator, he thrives in customer-facing engagements, translating complex scientific insights into hands-on RBQM solutions. By bridging sales and marketing through clear, consultative communication, Julien accelerates adoption, deepens client relationships, and delivers measurable impact across the healthcare and life sciences sectors.

Moderator 3 of the webinar: <p>Keith Dorricott, MBB<br>Lead Instructor<br>(MyRBQM Academy)</p>

Keith Dorricott, MBB
Lead Instructor
(MyRBQM Academy)

A Master Black Belt since 2007, Keith applies Lean Six Sigma to optimize clinical-trial workflows, reengineer processes, and drive performance metrics. A frequent speaker at SCOPE and the MCC Summit, he makes complex methodologies practical. He leads the mindsON RBQM Expert Working Group and facilitates Avoca Quality Consortium workstreams on 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

QbD/RBQM in a trial starts long before a participant is screened. It is trying to pre-empt issues and minimize them up-front. Once the trial begins, though, reality hits - new risks and issues emerge, some identified risks are not as great as were thought initially, and not all the risk controls may be as effective as planned. Risks and their controls need regular review. In this workshop, we will discuss some emerging best practices in this area. We will demonstrate how Cyntegrity's MyRBQM Portal can simplify the review and keep it on track so that the risks to trial participants and data are always kept at a minimum.


About "actON QbD" Workshops

Building on the success of our mindsON RBQM workshops, we're excited to introduce the actON QbD series. These workshops combine Quality by Design (QbD) principles with practical, technology-driven demonstrations using the MyRBQM Portal.

Each session highlights a specific use case, such as Protocol Design, Central Monitoring, Medical Monitoring, or many others. A subject matter expert will introduce the selected use case, followed by a live demonstration showcasing how the MyRBQM Portal supports and enhances the process.

Unlike the system-agnostic mindsON RBQM series, actON QbD offers a unique opportunity to explore AI-augmented workflows in action. The workshops demonstrate applying Cyntegrity's technology across various scenarios to deliver efficiency, precision, and actionable insights.

Join us to discover how Quality by Design can be brought to life across countless use cases, transforming workflows with actionable, technology-driven insights.

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