- 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
- Turning unstructured data transfer agreements and operational workflows into validated, version-controlled intake configurations
- Automating schema mapping, transformation, reconciliation, quality control, and schema-drift detection
- Combining AI-assisted configuration with deterministic execution, traceable evidence, and human exception review
- FDA Critical Path Initiative
- Critical Path Institute and FDA biomarker qualification
- Biomarkers as drug development tools in rare disease
- Identifying where AI can enhance clinical trial processes for rare disease programs
- Overviewing common challenges when introducing AI to clinical processes
- Successfully implementing AI within teams to avoid delays and implementation challenges