In the case of new drug-based therapies, the United States Food and Drug Administration (FDA) requires the conduct and results of a clinical trial to follow a regulation commonly referred to as 21 CFR Part 11. This regulation also applies to creating approvable, usable artificial intelligence (AI) for use in clinical workflows. This is crucial for pharmaceutical and healthcare organizations, as AI models have the power to accelerate clinical trials and improve patient care by intelligently interpreting data and feeding downstream systems, helping researchers save time and money.
