AI compliance intelligence for clinical research
Regulatory frameworks for AI in drug development are converging fast. We map the landscape, break down each framework, and provide tools to assess your readiness.
Compliance guide series
FDA's 7-step AI credibility framework
Step-by-step breakdown of the risk-based credibility assessment with clinical trial and manufacturing examples.
EMA reflection paper on AI in the drug lifecycle
How the EMA's lifecycle approach maps specific requirements to each development stage. Risk categories, GxP compliance, and comparison with the FDA framework.
GAMP 5 & the ISPE AI guide
Translating the 290-page framework into actionable validation approaches for GxP environments.
21 CFR Part 11 in the age of AI
Electronic records, audit trails, and model versioning for AI systems.
VIDS: imaging dataset provenance benchmark
Four of the most-cited public medical imaging datasets average 29% compliance against a new open standard. On provenance specifically, it's 8%. What that means for sponsors, dataset publishers, and submission teams.
Where FDA and EMA met: the ten joint AI principles
In January 2026 the FDA and EMA published ten shared principles for AI in drug development. Non-binding, but a forward indicator: the FDA's context-of-use and model-risk logic going transatlantic, and a map of where guidance hardens next.
EU AI Act & pharma
Mapping risk classification tiers to specific clinical research use cases.
AI vendor qualification
How to assess and manage AI suppliers for regulated use.