Archives: Agenda

Concept: This is an audience-led panel where data experts respond in real time to the most pressing data management challenges attendees are dealing with today. The conversation is driven by live Q&A with questions that have been submitted on Slido during the session

Takeaway: Attendees will leave with a clear view of the most pressing data management challenges impacting organizations right now and leave practical, immediately usable strategies to address them

• Traditional data management focuses on harmonization and data standards; but AI now requires rich metadata, semantic context, and governed relationships to effectively understand data as humans do
• Embedding and centralizing metadata, governance, and business context directly into the data platform’s process (“shift-left”) improves consistency and accuracy of context capture
• Applying this approach to SDTM and clinical submission data can help accelerate FDA submission activities by enabling AI-assisted generation, validation, traceability, and review of regulatory deliverables using a governed clinical context.

• Where RWD/RWE fits in the evidence lifecycle: Understand use cases before trial, during trial, and after trial.
• Role of RWD in trial execution
• Benefits of RWD/RWE in strengthening submissions

• Key trends reshaping clinical data management and how leading teams are responding
• Looking at the biggest operational and technology challenges and overviewing practical solutions
• What to expect over the next 3–5 years and how to stay ahead in capability, speed, and quality

Panel seat reserved for event sponsor

• Defining agentic AI and its capabilities to understand how it works and how it differs from automation and traditional rule-based workflows
• Understanding where it fits in regulated clinical environments and how it could be used to enhance clinical processes
• Evaluating real-world use cases and identifying actionable opportunities to scale and apply Agentic AI in data teams