How to tell demo-ware from deployable agentic AI in clinical trials: determinism, audit trails, 21 CFR Part 11, constrained architectures, and vendor questions.
Independent QC re-programming costs 30–50% of clinical programming effort. An AI framework matched 97.1–100% of variables while keeping independence intact.
Free-form agent loops break down in GxP clinical programming. Structuring the work as a typed process DAG makes LLM agents reliable, replayable, and auditable.