When people think about AI and IND documentation, the most intuitive idea is often: “AI can help write the documents.” But if text that was previously drafted by a medical writer is simply generated by AI instead, the underlying workflow has not fundamentally changed. The greater impact of AI on IND document development may not be about who writes the words, but about changing how documents are produced. IND Documents Rarely Start from a Blank Page Protocols, Investigator’s Brochures (IBs),...

Clinical study design has never been simply about writing a Protocol. Before formal drafting begins, the development team must already address a series of interconnected questions: What is the objective of the study? Who is the target population? How should dose and administration be structured? Which safety signals need to be monitored? How should endpoints be defined? Under what circumstances should the study be stopped or modified? As generative AI enters clinical development workflows,...

When a Protocol, Investigator’s Brochure (IB), or another clinical development document is delayed, the most intuitive reaction is often: “Is the writing taking too long?” But in actual clinical development work, the causes of document delays often emerge long before a writer begins drafting. The data have not been fully organized. Different versions conflict with one another. A key decision has not yet been finalized. Input from a functional team is still pending. In some cases, no one is...