In medical and regulatory writing workflows, discussions about AI often default to speed—draft faster, iterate faster, review faster. From the perspective of regulatory reviewers, however, speed alone rarely improves outcomes. Reviewers are responsible for evaluating safety, efficacy, and scientific integrity, and those responsibilities depend far more on context, traceability, and confidence than on how quickly a document was produced. Reframing AI’s role around the reviewe

AI hallucinations are often described as unpredictable failures—or as evidence that generative AI can’t be trusted in regulated environments. That interpretation is understandable, but incomplete. In reality, hallucinations occur because large language models generate text based on probability, not verification. They are a predictable result of how AI systems express confidence when certainty is unavailable. Once that’s understood, hallucinations become easier to anticipate

Safety narratives serve as a critical component of clinical trial documentation, providing a comprehensive account of a patient’s...