Pharmaceuticals and biotech / Pharmaceuticals
Merck & Co.: Drafting clinical study reports
- Company
- Merck & Co.
- Country
- United States
- Adoption stage
- Limited operation
- Source published
- Date basis
- The date the source was published. It can differ from the date adoption started.
- How the source was checked
- Read the full source text
The work problem
A clinical study report (CSR) is a core document submitted to regulators. The company said teams of medical writers have traditionally sifted through thousands of pages of clinical data over a period of months to write one. Writers must resolve conflicting data, verify results and build narratives in highly specific regulatory language. The company said that despite wide interest in generative AI, companies have faced challenges building a platform for this work.
Technology and data
Merck co-developed an internal generative AI platform for this work. The platform combines large language models (LLMs) with advanced table pre-processing and handles table mapping, data extraction, styling and validation. It was designed to operate under rigorous oversight by qualified medical writers. To integrate the LLMs, the company revamped its operations and trained teams in skills such as prompt engineering and data pipelines. The platform has been used across multiple studies.
Results
The company said the time to create a fully human reviewed CSR first draft fell from an average of 180 hours to 80 hours. It said errors in categories such as data, messaging, citations, terminology and typography fell by 50 percent. It said the platform can deliver a first draft in as little as five minutes. The company said it was scaling the platform across its late phase pipeline by the end of 2025.
Limits and open questions
The source does not say how many reports or what period the 180 to 80 hours average covers. Results after the platform was extended across the late phase pipeline are not in this source.
Sources
Compiled from public sources. These are not results from ATF Works customers.