Archives: Agenda

Case report forms are the foundation of clinical data collection. They determine what data is captured, how it is captured, and how much confidence there can be in the result. Yet in many organizations, forms are still built in Excel, Word, or ad-hoc formats that rarely align with EDC requirements or with each other.

This session examines how that inconsistency can affect the clinical data lifecycle from study build through regulatory submission, and explores the role of high-quality CRF design, standards, reusable content, and technology in improving consistency, efficiency, and traceability. The session will also demonstrate how these concepts can be put into practice through CRF creation and EDC execution, supported by a real-world case study.

• 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

• 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

• 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

• 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

• FDA Critical Path Initiative
• Critical Path Institute and FDA biomarker qualification
• Biomarkers as drug development tools in rare disease