Risk-Based Monitoring in Clinical Trials: An Evolution of Practices During the COVID Pandemic

The industry embraced an enormous shift during the global pandemic. This panel will report out on a two-year analysis conducted on over 6,000 clinical trials. We looked at the study-level and surveyed how risk-based and approaches are being adopted


Session Chair(s)

Brian  Barnes, MA

Brian Barnes, MA

Director, Risk Management Strategy, Global Clinical Development Operations

BioNTech, United States

Brian has 17 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM Working Group and presented and published on RBQM at industry meetings, conferences, and journals. Brian received his Bachelor of Science in Kinesiology from San Diego State University and Master of Art in Human Physiology from the University of Texas at Austin.



Nicole  Stansbury

Nicole Stansbury

Principal Consultant

BioTex Consulting LLC, United States

Nicole Stansbury, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based monitoring strategy, process and tools. Nicole has 30 years of experience in the industry beginning as a study coordinator in a multi-therapeutic site followed by 21 years at a large, global CRO where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into leadership roles.

Paula Jo Butler, MA

Paula Jo Butler, MA

Senior Director, Operational Transformation and Performance (OTP)

IQVIA, United States

Paula Jo Butler has over 35 years of experience in the Clinical Research Industry serving roles within Biostatistics and Project Management. She is currently IQVIA’s Senior Director of Operational Transformation and Performance (OTP). Her leadership experiences include oversight of Phase I-IV studies, NDA Management, Directorship of Strategic Alliances, and Global Leadership of the Project Management Support Office. Paula currently leads IQVIA’s Risk Based Monitoring (RBM) team responsible for RBM Project Leadership and Customer Support, change management, communication and continuous process improvement. Paula is a member of ACRO’s RBQM working group.

Lauren  Garson

Lauren Garson

Senior Director, Clinical Strategy

Veeva Systems, United States

Lauren joined Veeva in 2018 and is a Sr Director in the Vault Clinical Operations Strategy team. She is responsible for Vault eTMF, SSU, CTMS and Payments for Enterprise level customers and is the lead strategist for Vault Risk Based Study Management. She is passionate about ensuring that the products that customers adopt from Veeva bring them value and help to bring needed treatments to patients sooner. Prior to Veeva, Lauren spent the majority of her career at Pfizer in the monitoring group working on process enablement and implementing large scale technology projects. Lauren is a member of ACRO’s RBQM Working Group. She holds a BS from Cornell University.

Jennifer  Stewart, MBA

Jennifer Stewart, MBA

Executive Director, Clinical Data Sciences

Premier Research, United States

As Executive Director, Jennifer Stewart coordinates the efforts of Premier Research’s global Clinical Data Sciences department, offering expertise in clinical data management and data surveillance. She plays an active role in corporate initiatives for improving quality, efficiency, and resourcing. Ms. Stewart is skilled in organizational strategy and operational delivery, managing projects against budgets and timelines while maintaining high quality standards. She is a member of ACRO’s RBQM Working Group. Ms. Stewart earned her MBA at Roosevelt University and a BS in biomedical engineering at Northwestern University. She is a Certified Clinical Data Manager (CCDM) through The Society of Clinical Data Management.