Press Releases

The Definitive Guide to RBQM for Experts and Beginners

King of Prussia, PA  – March 11, 2021: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced that it is proud to be sponsoring RBQM Live on behalf of the industry. The adoption of Risk-Based Quality Management (RBQM) is accelerating, and it is more important than ever for the industry to share its expertise. This two-day virtual event is a definitive guide for anyone working with RBQM – from experts to beginners. You can register now for a free E-Pass.

Taking place from May 20-21, 2021, RBQM Live is a chance to discuss how we can continue to leverage RBQM to build safer, more efficient clinical trials of the future.

Ken Getz, Professor of TUFTS CSDD, is the keynote speaker for day one (May 20). Ken will provide a compelling look at how the COVID-19 pandemic has transformed the drug development operating environment and explore where the industry will be post-pandemic.

Sy Pretorius, Parexel's President, Clinical Development and Chief Medical Officer, is the lead-off speaker for day two (May 21) exploring the impact of COVID-19 on adoption of digital applications, decentralized models and remote monitoring. Sy will discuss clinical data challenges and the growing imperative to adopt risk-based thinking and management throughout clinical development, illustrated with case study snapshots.

Commenting on the event Patrick Hughes, Co-Founder and Chief Commercial Officer at CluePoints said, “CluePoints is honored to play a part in bringing this extraordinary industry event to fruition. The speaking delegation represents a ‘Who’s Who of RBQM’ and the agenda will cover topics relevant to both Subject Matter Experts and RBQM Rookies alike. The fact that the online program is dedicated to all aspects of Risk-Based Study Planning and Execution is testament to the huge strides that the industry had made in the past 12 months in moving this game-changing topic from a nice-to-have to a must-have for Sponsors and CROs. We can’t wait to see the speakers in action and contribute to the discussions and debate.”

Both days will focus solely on RBQM and feature the industry’s leading innovators. Highlights include:

Day 1 – Thursday, May 20, 2021

• Powered by the Pandemic – How Pharma Has Succeeded and How It Will Continue to Embrace Operational Changes Facilitated by COVID-19. Ken Getz, Professor of TUFTS CSDD, provides a compelling look at how the pandemic has transformed the drug development operating environment and where it will be post-pandemic.
• The Evolution from RBM to RBQM – How Far Have Risk-Based Approaches Come in 10 Years and Where Do We Go Next? Jonathan Rowe, Head of R&D Quality and Risk Management, ZS Associates, provides a review of the cross-functional use cases for RBQM and the role of regulators and guidelines in driving change.
• RBQM Best Practice Defined by Leading Industry Working Groups. A panel discussion led by an esteemed panel of luminaries from Clinical Trials Information Initiative (CTTI), Metrics Champion Consortium (MCC), and Association of Clinical Research Professionals (ACRO) who have driven guidance for the Industry.

Day 2 – Friday, May 21, 2021

• The Future of Clinical Trials is Now. Sy Pretorius, Parexel's President, Clinical Development and Chief Medical Officer, explores the impact of COVID-19 on adoption of digital applications, decentralized models and remote monitoring.
• Has RBQM Lived up to TransCelerate's Expectations? A panel discussion with the original founders of RBQM from TransCelerate who will give their views on the state of Risk-Based approaches and where the industry is seeing the biggest benefits.
• The Application of RBQM to Rare Disease and Small Trials. Jacqueline Gough, Director, Central Monitoring, Alexion, will provide best practice for the use of Risk-Based Quality Management in small and rare disease trials.

For a full agenda and more about the event visit rbqmlive.com. More expert speakers will be announced shortly so keep an eye on the website for updates.

Visit rbqmlive.com/register-for-rbqm-live to book your free E-Pass today.

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 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 increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBx.