Press Releases

Industry-leading Risk-Based Quality Management event focuses on the maturity of RBQM, its increasing value, and the vision for the future

CluePoints Hosts RBQM Live 2022 as the Premier Event Sponsor

King of Prussia, PA – August 30, 2022: Industry-leading risk-based study execution and data quality oversight software provider, CluePoints, is proud to announce its role as the premier event sponsor of RBQM Live 2022. The two-day virtual event is a must-attend for everyone currently working with or planning to adopt risk-based quality management (RBQM) in clinical trials. The event provides a unique opportunity to discuss the current landscape, look to the future, and share practical experiences. There is something for everyone to ensure RBQM success, no matter the size of the organization or the experience of the delegate.

Day 1, on September 8^th, will focus on RBQM Maturity — Insights into Current Trends and Increasing Value. The keynote address, “How the Evolving RBQM Landscape Will Reinforce the Way We Improve Efficiencies & Add Value,” will be given by Professor Ken Getz of the Tufts Center for the Study of Drug Development.

Other highlights include panel discussions on interpreting quality tolerance limits (QTLs), moderated by CluePoints’ Chief Scientific Officer Steve Young, and accounting for the risks of decentralized clinical trials as sources of data increase. In addition, there will be a briefing on the ICH E6 (R3) and E8 (R1) guidance updates, led by Jonathan Rowe, Principal, Head of R&D Quality, Operations and Risk Management at ZS Associates, and a session around RBQM Diversification: tSDV, tSDR, Dynamic Site Monitoring Strategies.

The theme for the second day, September 9^th, is Advancing RBQM — Where Are We Heading in the Future?  The keynote for day two will feature a fireside discussion with Demetris Zambas, Global Clinical Operations Leader, Pfizer, and Mayank Anand, VP and Global Head Data Strategy, Management and Centralized Monitoring, GSK debating “How AI and Machine Learning play an essential part in the future of RBQM.”

In addition, there will be discussions around RBQM best practices defined by leading working groups. Rounding out the event will be two insightful panel discussions. One will focus on leveraging RBQM in new ways you never envisioned and then the event will close with a discussion around what transformative outcomes from the last two years are here to stay.

Patrick Hughes, CluePoints Co-Founder, enthuses: “Risk-Based Quality Management adoption continues to grow rapidly and there are many more companies now on the journey than ever before. Further, as market factors drive the rapid growth of decentralized clinical trials, there is even greater scope for organizations to embrace RBQM to ensure effective oversight of the various disparate data sources. RBQM Live 2022, sponsored by CluePoints, will host some of the industry’s leading speakers to discuss the impact and value of RBQM today and what we can all look forward to in the near future. RBQM is here to stay and these sessions will reinforce what you can and should do to ensure success for you and your team.

The definitive guide to RBQM for beginners and experts alike occurs on September 8 and 9, 2022. Specialists from across the sector will gather to consider the current climate for adopting RBQM by CROs and sponsors, as well as looking ahead to implications for the future.”

For more information on RBQM Live 2022: https://rbqmlive.com/agenda-2022/

NOTES TO EDITORS:

RBQM Live 2022 brings together industry experts, clinical trial specialists, and curious listeners to share insights and discuss the acceleration of RBQM.

The full agenda (all times listed are EST):

Day 1: September 8^th 2022

• 08:00 am - 08:45 am: Keynote: How the Evolving RBQM Landscape Will Reinforce the Way We Improve Efficiencies and Add Value (Research Study Findings). Speaker: Ken Getz, Professor, Tufts Center for the Study of Drug Development.
• 08:45 am - 09:30 am: Compliance is Key: ICH E6 (R3) & E8 (R1) Guidance Update.  Speaker: Jonathan Rowe, Principal, Head of R&D Quality, Operations and Risk Management at ZS.
• 09:30 am - 10:30 am: Panel: Interpreting QTLs Through the Lens of Where They Are Today and Where They Are Evolving. Speakers: Marion Wolfs, Senior Director Risk Management & Central Monitoring, Janssen; Joanna Florek-Marwitz, Data Management/Data Science/RBQM Senior Leader, UCB; Steve Gilbert, Senior Director Statistics, Pfizer. Moderator: Steve Young, Chief Scientific Officer, CluePoints.
• 10:30 am - 11:30 am: RBQM Diversification: tSDV, tSDR, Dynamic Site Monitoring Strategies.  Speakers: Lesley Lardino, Senior Director, Data Management and Central Monitoring, Astellas; Peter Stokman, Business Lead Clinical Data Reporting & Visualization Environment – Bayer; Jacqueline Gough, Senior Director – CTM, Syneos Health.
• 11:30 am - 1:00 pm: Panel Discussion: Understanding the Risks of Decentralized Trials as Sources of Data Increase and How to Plan for Success Proactively. Speaker: Cris McDavid, Associate Director, Global Clinical Operations, RBQM, Parexel; Joseph Dustin, Vice President of Product Strategy for eCOA at Medable; Craig Lipset, Co-Chair, Decentralized Trials & Research Alliance.

Day 2: September 9^th 2022

• 08:00 am - 09:15 am: Keynote: Fireside Chat: How Will AI and Machine Learning Play an Essential Part in the Future of RBQM? Speakers: Demetris Zambas, Global Clinical Operations Leader, Pfizer; Mayank Anand, VP and Global Head Data Strategy, Management and Centralized Monitoring, GSK.
• 09:15 am - 10:15 am: RBQM Best Practices Defined by Leading Industry Working Groups.  Speakers: Linda Sullivan, Senior Advisor, Metrics & Performance Management WCG; Nicole Stansbury, Vice President, Global Clinical Trial Management, Syneos.
• 10:15 am - 11:30 am: Panel Discussion: Leveraging RBQM in Ways You Never Envisioned (Quality, Safety Review, etc.) Speakers: Amit Gulwadi, Vice President- Head of Transformation, Alexion; Blake Jensen, Quality and Compliance Executive, Adagio.
• 11:30 am - 01:00 pm: Panel: The New Risk-Based Norm – What Transformative Outcomes (From the Last Two Years) Are Here to Stay? Speakers: Katherine Taylor, Senior Director/Head Risk Evaluation and Adaptive Integrated Monitoring, Merck; Olivia Feiro, Director, Risk Management and Analytics, CSL Behring; Lynne Cesario, Senior Director, Risk Based Monitoring Program Lead, Pfizer.

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About CluePoints

CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight software. Our products utilize comprehensive statistical algorithms to determine clinical trial data quality, accuracy, and integrity, 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 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 to global regulatory guidance. The result is increased operational efficiency, lower costs, and reduced regulatory submission risk as part of the industry paradigm shift to RBx. 

Media Contact 

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