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June 25, 2025 1:12 pm ET

New platform utilizes advanced data engineering and LLMs to enhance clinical study report development, helping deliver medicines to patients faster

RAHWAY, N.J., June 25, 2025 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, is evolving its technology architecture and business capabilities to remove complexities within the clinical trial process. As an extension of this large-scale business and technology rebuild, Merck has implemented a new internal generative-AI-powered platform that significantly reduces the time needed to produce critical-path clinical study documents to get lifesaving medicines to patients faster. In collaboration with McKinsey & Company and its AI arm, QuantumBlack, Merck technologists and clinical trial experts have developed new solutions leveraging large language models (LLMs) to expedite the creation of first drafts of clinical study reports (CSRs), from two to three weeks to just three to four days. This time saved accelerates the speed at which Merck’s products are available to health care providers and patients.

Clinical trials require significant time and labor investment. In use cases of the new platform across multiple studies, Merck has successfully:

• Reduced the time to create a fully human reviewed CSR first draft from an average of 180 hours to 80 hours.
• Increased the quality of CSR drafts – as measured by reducing the number of errors by 50% – in categories such as data, messaging, citations, terminology and typography.

CSRs are traditionally labor-intensive, requiring teams of medical writers to sift through thousands of pages of clinical data over a period of months. Writers must resolve conflicting data, verify results and construct narratives using highly specific regulatory language. Despite widespread interest in applying generative AI (gen AI) to streamline this work, companies have faced challenges building a platform that generates full CSRs of regulatory quality. Earlier this year, Merck and McKinsey’s joint team of more than 80 data science, AI, life science technologists and medical experts, working across three continents, produced and submitted the first live CSRs using the new proprietary platform.

“Our innovative work in Information Technology is focused on getting our products to patients faster,” said Matt Studney, senior vice president of Merck Research Laboratories Information Technology. “This work puts AI in the hands of our medical writers and across our enterprise, creating new efficiencies for our skilled R&D teams, who are integral to our innovation and success.”

Carefully designed to operate with rigorous oversight by qualified medical writers, the co-developed platform integrates advanced table pre-processing with gen AI authoring. In as little as five minutes, it can deliver a high-quality first draft, managing table mapping, data extraction, styling and validation. To integrate the LLMs, Merck revamped its operations and trained teams in prompt engineering, data pipelines and other skills critical to overseeing the platform.

Merck is in the process of scaling this platform across its late phase pipeline by the end of the year. Learn more about how Merck is using data science, AI and machine learning to help overcome bottlenecks in drug discovery, research and development here.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:

Toneisha Smith

(609) 455-6000

toneisha.smith@merck.com

Ned Ehrbar

(732) 594-1487

ned.ehrbar@merck.com