Expert Speaker Line-Up Revealed for Industry-Leading RBQM Event

CluePoints Supports Launch of RBQMLive 2024 as Premier Event Sponsor

KING OF PRUSSIA, Pa., Sept. 4, 2024 /PRNewswire/ -- CluePoints, the premier sponsor of RBQMLive and provider of Risk-Based Quality Management (RBQM) and Data Quality Oversight Software, has revealed the full agenda and speaker line up for the award-winning RBQMLive event. RBQMLive is the industry-leading event for anyone working with, or interested in risk-based quality management approaches.

RBQMLive, taking place on September 24-25, 2024, is a free, virtual event offering attendees the opportunity to immerse themselves in cutting-edge discussions, workshops and networking opportunities. From transformative shifts in RBQM to global regulatory updates and the emergence of new technologies, this virtual event equips attendees with all they need to continue their RBQM journey and drive further efficiency gains across all clinical trials.

Last year's event was attended by more than 1,000 delegates from over 375 organizations. RBQMLive 2024 is set to be even bigger and better with new opportunities to collaborate and drive positive change within the clinical trial landscape.

On day one, the keynote address, Unlocking the Path to RBQM Maturity, will again be delivered by Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development. Ken will explore evidence-based insights showcasing the increase in RBQM adoption, uncover factors driving and hindering RBQM usage and share actionable insights from the recent empirical research findings.

Other day one highlights include:

• Taking RBQM into New Dimensions – Understanding the Risk-Based Data Management (RBDM) Revolution with Miguel Valenzuela, Associate Director of Clinical Operations, RBQM at Alnylam, Paul MacDonald, Senior Director Vault CDMS Strategy at Veeva and Patrick Nadonly, Global Head, Clinical Data Management, Sanofi.
• The Emergence of AI & ML in RBQM: What's here now and what is to come? with Marcin Makowski, Head of Centralized Monitoring & Data Analytics, GSK and Bob Zambon, Vice President, Technology Strategy & Strategic Partnerships, Syneos Health.

Key themes on day two include the future of RBQM, enhanced data quality and optimizing study oversight. Highlights include:

• RBQM Industry Guidance Evolution – Adapting to Modernization with Olivia Feiro, Director, Risk Management & Analytics at CSL Behring, Lotte Smets, Director of Data Management at Julius Clinical and Daniel DiJohnson, Risk-Based Quality Management SME, Senior Manager, Parexel.
• Enhancing Data Quality through Advanced Audit Trail Review with Paola Peshkepija, Senior Associate Central Monitor, Pfizer and Jennifer Nielsen, Senior Specialist, Clinical Data Management, Lundbeck.
• Integrated Data Review: Optimizing Study Oversight with Brian Barnes, Director of Risk Management Strategy – Process Excellence & Oversight at BioNTech, Jess Thompson, Founder of Clinical Research Project Management Association and Alaine Heffernan, Director Centralized Monitoring, Allucent.

Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, commented, "Risk-based quality management is evolving, and industry adoption is increasing fast. RBQMLive is a unique event which brings together global specialists, industry experts and anyone who is interested in finding out more about this transformative approach to managing clinical trials. This year's exciting program looks set to make RBQMLive 2024 bigger and better than ever and we urge everyone to register for their free place."

RBQMLive 2024 takes place virtually from September 24-25. Visit rbqmlive.com/rbqm-live-2024-agenda for more information and to register.

About CluePoints

CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.