ACDM26 Speakers

Isabel Villanueva

Senior RBQM Operations Consultant at TRI

Isabel Villanueva is a Senior RBQM Operations Consultant at TRI – the RBQM Experts, where she helps clinical research organizations optimize their quality management strategies through risk-based approaches. With over 15 years of experience in the clinical trials industry, Isabel has spent the last three years specializing in Risk-Based Quality Management (RBQM), supporting sponsors and CROs in implementing scalable, efficient quality systems that enhance trial oversight while maintaining patient safety and data integrity.

At TRI, Isabel works directly with clients to design and operationalize RBQM frameworks tailored to their unique needs, drawing on her extensive industry background to bridge the gap between regulatory requirements and practical implementation. Her expertise spans risk assessment methodologies, critical data and process identification, and the integration of centralized monitoring strategies that deliver measurable improvements in trial quality and efficiency.

Isabel is passionate about advancing the adoption of RBQM across the industry and sharing practical insights that help teams move from traditional quality approaches to modern, risk-based strategies.