Using Traditional AI and LLMs to Automate Complex and Critical Documents in Healthcare
Informed Consent Forms (ICFs) are critical documents in clinical trials. They are the first, and often most crucial, touchpoint between a patient and a clinical trial study. Yet the process of developing them is laborious, high-stakes, and heavily regulated. Each form must be tailored to jurisdictional requirements and local ethics boards, reviewed by cross-functional teams, and written in plain language that patients can understand. Producing them at scale across countries and disease areas demands manual effort and creates major operational bottlenecks. We used a combination of traditional AI and large language models to autodraft the ICF across clinical trial types, across countries and across disease areas at scale. The build, test, iteration and deployment offers both technical and non technical lessons learned for generative AI applications for complex documents at scale and for meaningful impact.
