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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Who’s Afraid of the Big, Bad EU AI Act?

The European Union’s Artificial Intelligence Act (EU AI Act) has become a significant milestone in the global regulation of artificial intelligence. As the world’s first comprehensive AI regulation, it introduces a risk-based framework designed to ensure the safe and ethical deployment of AI technologies. For industries relying heavily on innovation, like biopharma clinical trials, understanding…

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