Merck, known as MSD outside the United States and Canada, has implemented an internal generative AI platform that drafts clinical study reports (CSRs), cutting the time to produce a first draft from two to three weeks to three to four days, the company announced in June 2025. The platform is part of a wider rebuild of Merck's technology architecture and business capabilities aimed at removing complexity from the clinical trial process.
CSRs are labour-intensive: medical writers sift through thousands of pages of clinical data over months, resolve conflicting data, verify results and write narratives in specific regulatory language. Merck says companies have struggled to build generative AI platforms that produce full CSRs of regulatory quality.
The co-developed platform combines advanced table pre-processing with generative AI authoring and handles table mapping, data extraction, styling and validation, producing a first draft in as little as five minutes. It operates under oversight by qualified medical writers. To integrate the large language models, Merck changed its operations and trained teams in prompt engineering, data pipelines and other skills needed to oversee the platform. A team of more than 80 data science, AI, life science technology and medical experts across three continents produced and submitted the first live CSRs on the platform in early 2025.
In use across multiple studies, the time to create a fully human-reviewed CSR first draft fell from an average of 180 hours to 80 hours, and the number of errors in drafts, in categories such as data, messaging, citations, terminology and typography, fell by 50%. "This work puts AI in the hands of our medical writers and across our enterprise, creating new efficiencies for our skilled R&D teams," said Dave Williams, chief information and digital officer. Merck said it was scaling the platform across its late-phase pipeline by the end of 2025.
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