Clinical Data Management
AI in Clinical Data Management: How to Move Fast Without Breaking Data Integrity
Key Takeaways AI can compress clinical data management (CDM) timelines, but only if you protect data integrity, traceability, and reviewability. Regulated CDM must treat AI as part of the computerized system landscape, including validation and trustworthy records, not a “black box helper.” FDA Part 11 guidance and FDA electronic systems guidance are practical anchors. Modern […]
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