As clinical trials modernize, the way that companies think about quality and risk in the design and conduct of a study must evolve as well. SCOPE’s 12th Annual Quality & Monitoring stream will provide an opportunity for clinical operations leaders to exchange best practices, case studies, and in-depth strategies for integrating a risk-based approach throughout the clinical research cycle, from study design to monitoring activities. Industry leaders in RBQM will come together alongside changemakers from other functional areas to collaboratively work towards integrating quality throughout clinical study. The program will also feature new technologies and innovative ways that studies are monitored and analyzed. This program will explore ways of leveraging RBQM technologies to achieve study plan goals, the impact of ICH E6 R3 on study conduct, the application of AI tools and data analytics to power a risk-based approach, and key insights for regulatory compliance.