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#217: Case Studies of Application of AI in Risk-Based Quality Management
Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-564-L04-P; CME 1.00; RN 1.00

This session will present multiple case studies illustrating the successful implementation of AI-driven RBQM solutions in real-world clinical trials. Attendees will gain insight into the practical applications of AI technologies.

Learning Objectives

Recognize the key benefits and challenges of applying AI technologies in RBQM; Identify insights into real-world examples of AI's impact on clinical trial risk management; Discuss strategies for integrating AI into existing RBQM frameworks to improve decision-making and compliance; Describe how AI enhances collaboration across clinical trial stakeholders and supports more proactive risk-based strategies.

Chair

Artem Andrianov, PhD, MBA

Speaker

Panel Discussion: AI Teammates in Trials - Elevating Risk Management and Human Insight
Brian Barnes, MA

Novo Nordisk’s Path to Integrated Quality and Risk Management with AI-Powered Study Builder
Bo Maach-Møller, MPharm

Unlocking AI Potential In RBQM: Today and Tomorrow
Cheng Su, PhD


Speakers
avatar for Artem Andrianov

Artem Andrianov

CEO, Cyntegrity Germany GmbH, Germany
With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical... Read More →
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian is a seasoned leader in clinical research, specializing in Good Clinical Practice (GCP) process excellence, risk-based quality management (RBQM), and global clinical operations across a range of therapeutic areas. With over two decades in pharmaceutical R&D, he has held pivotal... Read More →
BM

Bo Maach-Møller

Vice President, Risk Based Quality Management, Novo Nordisk A/S, Denmark
As a Vice President of Clinical Operations and Risk Based Quality Management, Regional Clinical Operations Director, Lean Six Sigma Black Belt, and many other Clinical Operations roles over the years, I bring an extensive and diversified experience in managing people and project initiatives... Read More →
CS

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical, United States
Cheng is the Executive Director of Data Sciences at BioMarin, where he leads RBQM transformation, AI innovation, and statistical support for research and early development. Prior to joining BioMarin, he led the development of centralized statistical monitoring and directed the Research... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

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