Posts Tagged ‘biopharma clinical trial’
Designing an Audit Trail for AI in Clinical Trials: Aligning with the EU AI Act
As artificial intelligence (AI) continues to transform clinical trials, ensuring transparency, accountability, and compliance has become critical. Central to achieving these goals is the implementation of a robust audit trail system. While the EU Artificial Intelligence Act (EU AI Act) does not explicitly define audit trail requirements for high-risk AI systems, it emphasizes the need…
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