The US FDA is piloting the use of AI for 'real-time' clinical trials.
The Story
This aims to accelerate data analysis and decision-making within ongoing studies.
Why It Matters
The US FDA piloting AI for 'real-time' clinical trials is a clear signal for European CROs and small biotech. Regulators are now actively exploring AI for faster data analysis and decision-making in studies. Your current manual or semi-automated processes will face pressure to adapt. This means preparing now for similar EU regulatory expectations under the AI Act, focusing on compliant AI integration for data review.
What To Do About It
Start by auditing your clinical trial data review processes. Assess where Microsoft 365 Copilot, using your existing tenant, could automate initial data checks. This builds internal AI competence securely, well before the August 2026 EU AI Act enforcement.
Sources
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