RBQMLive 2025 Highlights Advancements in Risk-Based Quality Management

CluePoints to Sponsor RBQMLive 2025



As the world of clinical trials continues to evolve, CluePoints stands at the forefront, sponsoring the fifth annual RBQMLive on September 25, 2025. This premier virtual event gathers experts from the clinical community to explore the latest advancements in Risk-Based Quality Management (RBQM), addressing the significant transformations in trial oversight and the use of data-driven strategies.

What to Expect at RBQMLive 2025



RBQMLive 2025 promises an enlightening lineup of discussions and presentations, aimed at enhancing understanding and implementation of risk-based methodologies. With over 1,500 attendees from more than 290 organizations logged in last year, expectations are set high for this year’s event. Key discussions will center around:

Unveiling the Financial Value of RBQM


A standout keynote address by Ken Getz, Executive Director at Tufts Center for the Study of Drug Development, will kick off the event. Partnered with Abigail Dirks, a data scientist, this session will dive deeply into the Net Present Value (NPV) analysis of RBQM, showcasing how proactive quality management can lead to measurable financial and operational improvements in clinical trials.

Transitioning to ICH E6(R3)


Featuring industry leaders like Cris McDavid, Dawn Anderson, and Leonie Christianson, a critical focus will be interpreting the new ICH E6(R3) principles. This panel will offer practical strategies for integrating innovative quality strategies into trial operations, which is essential as the industry adapts to changing regulatory expectations. Moderated by Parexel, this session promises to be an eye-opener for professionals aiming to stay ahead in their field.

The Impact of AI on RBQM


Artificial Intelligence is transforming various sectors, and clinical trials are no exception. Drew Garty, CTO of Clinical Data at Veeva Systems, will present a session dedicated to how AI is enhancing quality and efficiency within RBQM. Attendees can look forward to insights on successfully leveraging AI technologies to improve trial outcomes while ensuring compliance with regulatory guidelines.

Why Attend RBQMLive?


The RBQMLive series, recognized for its excellence, provides a unique platform for professionals in the clinical space to connect, share, and learn. Richard Young, Chief Strategy Officer at CluePoints, emphasized the importance of this year’s theme, stating, "The new ICH E6(R3) guidance positions RBQM and integrated data review at the forefront of trial operations. Our goal is to educate the industry on how these approaches can not only meet but exceed regulatory expectations."

Registration Details


Participating in RBQMLive is free of charge, making it accessible to anyone looking to explore the cutting-edge advancements in clinical trial management. Interested participants can register and view the complete agenda through the RBQMLive website.

Do not miss this opportunity to learn from the experts and network with influential industry peers as we shape the future of clinical trials together!

About CluePoints


CluePoints is recognized as a leader in Risk-Based Quality Management and Data Quality Oversight. With state-of-the-art statistical methods and AI-integrated solutions, CluePoints strives to ensure the integrity and accuracy of clinical trial data. The company’s commitment to guiding organizations in risk assessment and management is backed by its alignment with global regulatory standards from agencies like the FDA and EMA.

Join us at RBQMLive 2025 to gain insights that will elevate your understanding of risk-based strategies in clinical research!

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