Vertex Pharmaceuticals’ application of LLMs to automate the development of Informed Consent Forms (ICFs) stands out not as a speculative proof-of-concept, but as a rigorously executed, business-driven innovation with clear, measurable outcomes. In a year when AI experimentation has proliferated, Vertex demonstrates what operational maturity in AI looks like in healthcare: targeted, grounded, and transformative without losing sight of compliance or patient experience.
ICFs are critical documents in clinical trials. They are the first, and often most crucial, touchpoint between a patient and a 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 therapeutic areas demands manual effort and creates major operational bottlenecks.
Vertex identified this challenge as a fundamental business problem directly impacting trial timelines and patient engagement. The response: the ICF Autodrafter, a custom LLM-powered application that automates the drafting of ICFs. Developed in partnership between Vertex’s Global Clinical Trial Operations and internal AI teams, this tool ingests a clinical trial protocol and ICF template and outputs a complete draft in minutes, cutting document preparation time by 90%.
This solution is not generic automation. The backend logic parses highly structured protocol documents, segments them, and feeds the relevant content into a carefully fine-tuned LLM that maps text to specific ICF fields (often across 20-30 pages). The front-end is designed for usability by site managers, with human-in-the-loop reviews baked in from the start. This system has already supported ICF creation for more than ten trials and has achieved near-perfect consistency (97%) with human-generated content, underscoring the speed, quality, and robustness of the solution.
What sets Vertex apart is its disciplined approach to enterprise AI. The company began with a clear business need, tested rigorously with A/B comparisons, iterated with feedback from end-users, and anchored all development within regulatory and ethical guardrails. Crucially, it is not replacing human oversight but elevating skilled teams by removing repetitive manual work and allowing users to focus on higher-value judgement and patient engagement.
The impact extends beyond efficiency. By standardizing and accelerating ICF production, Vertex can reduce delays in trial start-up and potentially get medicines to patients faster, without compromising safety, compliance, or clarity. Furthermore, it also lays down a scalable model for future AI-driven document workflows across the organization.
This is healthcare AI as it should be: enabling specialists to do better work, faster. For its focus, rigor, and patient-first execution, Vertex Pharmaceuticals has proven great advancements with data and AI in this essential space.
