Merck and McKinsey GenAI tool cuts clinical report drafting from weeks to days, boosting R&D speed and precision.
Merck and McKinsey have teamed up to modernize clinical study reporting with a GenAI first platform. These documents are essential for drug approvals but historically take weeks of manual work. Their new AI-powered system reduces this process to just three to four days, down from nearly three weeks. GenAI generates first drafts in minutes. Enabling faster reviews and freeing up medical writers for deeper analysis.
The platform, developed with QuantumBlack, McKinsey’s AI arm, uses a blend of commercial and open-source models tailored to Merck’s regulatory standards. It automates table preprocessing, data extraction, formatting, and content generation across 14 key report sections. With a medical writer still in the loop, it ensures both speed and accuracy. Drafting time has been cut by 100 hours per report. While error rates have dropped by half.
This collaboration goes beyond technology. Merck redesigned internal workflows and upskilled teams to integrate AI seamlessly. The tool enables consistent output quality and supports fast scaling across Merck’s late-phase pipeline. A shared library of prompts and AI modules is also in development to further streamline the process.
By embedding GenAI into core R&D workflows, Merck and McKinsey are demonstrating how AI can drive real efficiency in pharma. The platform not only accelerates regulatory submissions . It also improves how insights are developed and shared. For an industry racing to bring therapies to patients faster, this marks a significant shift in how innovation is delivered.