42 CFR Part 11 mandates clinical trial registration and results reporting on ClinicalTrials.gov to ensure transparency. AI can automate compliance, analyze trial data for insights, and optimize patient recruitment. These regulations create opportunities for using AI platforms like Neuroute to streamline clinical trial processes and enhance efficiency.

The UK’s new clinical trial regulations aim to speed up approvals, improve transparency, and enhance patient involvement. Key changes include a 60-day approval timeline, mandatory trial registration and result publication, simplified consent for low-risk trials, and guidance on diversity in recruitment. Research Ethics Committees will have more flexibility, and 20 new clinical research hubs will be established. For AI, these changes create opportunities to automate compliance, optimize trial design, improve patient recruitment, and enhance data transparency, making clinical trials faster and more efficient.