Talk Risk-Based CDM track
Mitigating Risk from RBDM Using Analytics, Visualization & AI/ML
Sun, Sep 28, 2025 · 4:15–5:30 PM EDT Room 337+338, Baltimore Convention Center
About this session
Session chaired by Dev Patel
Description:
Although regulatory guidance encourages trial sponsors to use risk-based strategies, a recent industry survey found that only 13% of professionals consider these approaches a top priority for their organizations in the coming year. As trials grow more complex and regulations change, adopting risk-based methodologies is often challenging. According to a survey by the Tufts Center for the Study of Drug Development, key obstacles include limited organizational knowledge, unclear value, and ineffective change management. Still, data management is a crucial area where risk-based methods can deliver real, measurable improvements today.
This talk will use real-world examples to highlight the benefits of risk-based data management (RBDM), showing how these practices streamline trial operations and improve efficiency while meeting regulatory requirements. By sharing insights from multiple trials and showcasing advanced tools like interactive analytics, automation, and AI/ML, the presentation will offer practical strategies and guidance for successfully adopting RBDM.
