The news: Merck is teaming with McKinsey for a generative AI (genAI) program that streamlines clinical study reports (CSRs). For context, CSRs are comprehensive summaries of the research, data, and results from clinical studies created as part of the submission process for new drug approvals.

Zooming in: Working with McKinsey’s AI arm QuantumBlack over the past 18 months, the two developed a genAI platform that reduces clinical study report (CSR) time from a previous 2 to 3 weeks down to 3 to 4 days.

• The average time to create a human-reviewed CSR draft dropped from 180 hours to 80 hours, per McKinsey.
• Errors were reduced by 50% across data, messaging, citations, terminology, and typography.
• Merck is rolling out the platform across its late stage drug pipeline by the end of the year.

Why it matters: Trimming time from medical writing can speed up approval and time to market. And Merck isn’t the only pharma looking to trim clinical trial report time and improve accuracy with AI.

• Novartis and Eli Lilly are investors in genAI company Yseop, which specializes in AI-assisted regulatory compliant medical writing. Sanofi and GSK are also Yseop customers.
• Indegene uses genAI to draft CSRs and clinical overviews (COs) using internal and external sources to search and determine potential questions, resulting in an 80% reduction in response time, per Indegene.

The takeaway: GenAI is ideal for time-intensive precise medical writing and frees content creators for oversight and strategic tasks. While Merck and some others are already using it for regulatory filings, those who stall or keep their pilots in the experimentation phase risk losing valuable time-to-market advantages.

Go deeper with our recent “Generative AI for Pharma Marketing” report for more.

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