Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches

WASHINGTON, DC

Quality by design (QbD) and risk-based monitoring (RBM) approaches facilitate clinical trial modernization by enhancing efficiency without compromising data integrity or participant protections. The U.S. Food and Drug Administration (FDA) has encouraged the use of QbD and RBM through many outreach...

Quality by design (QbD) and risk-based monitoring (RBM) approaches facilitate clinical trial...

Enhancing Adoption of Innovative Clinical Trial Approaches

A two-day hybrid Public Workshop on March 19-20, 2024 to identify these barriers and potential strategies across all stakeholders. The goals of this workshop are to identify key challenges in clinical trial modernization efforts around the following topics: • Regulatory and Compliance...

A two-day hybrid Public Workshop on March 19-20, 2024 to identify these barriers and potential...