From One-Size-Fits-All to End-to-End Risk Based Quality Management

About this session

Session: RBQM ADOPTION AND OPERATIONALISATION

Historically, site monitoring was generally conservative in planning and execution, and significantly drove study cost. By shifting gears from One-Size-Fits-All towards End-to-End RBQM, we have enabled a comprehensive approach, leveraging cross-functional risk assessment; technology; and adaptive on-site, off-site and Centralized Monitoring activities to ensure data quality and subject safety. In our RBQM implementation journey, we have learned to be more focused and disciplined in our assessment of study-specific needs and our way of working to optimizing study and data validation monitoring.

Speaker

• JF

  Joanna Florek-Marwitz

  Head of Risk Management & Centralized Monitoring · UCB Biosciences GmbH

  Speaker