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Next Generation Generative AI Regulatory Writing Software

AI enabled solutions accelerate regulatory and medical writing processes, enhancing quality and efficiencies


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Published:Jun 17, 2024
|2 min read
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Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today unveiled its next generation CoAuthor regulatory writing software. CoAuthor is an advanced writing platform designed for medical writers. It combines generative AI, document templates, MS Word integration, and structured content authoring tools. CoAuthor accelerates the creation of regulatory documents while maintaining a “human in the loop” approach to the use of generative AI. 

Medical writing is a critical part of drug development. It relies on manual processes which have not changed significantly over the past two decades. Drug development pipelines increasingly comprise precision medicine therapies that depend on advanced biomedical knowledge. Today’s medical writers must translate complex study designs and data into documents that contextualize research results for different audiences. They need better ways to synthesize numerous sources of knowledge and securely connect them to their data and documents.

“Life Sciences companies are looking for secure, generative AI solutions that are specialized for drug development,” said William Feehery, PhD, Certara CEO. “Certara has the proven technical and scientific expertise required to maximize the potential of generative AI for regulatory and medical writing.”

Built by writers, for writers, CoAuthor is easy to use and combines a life science specialized, secure, client specific GPT with structured content authoring and comprehensive eCTD regulatory writing templates. With CoAuthor, medical writers can streamline the document drafting process, allowing more time for content curation, collaboration, and quality control. Fully integrated with Microsoft Word, CoAuthor enables writing teams to use familiar tools, systems, and processes while ensuring consistency and quality. Certara clients will have the flexibility to work with CoAuthor as part of a comprehensive regulatory writing solution, at the program level and across the enterprise.

“We’ve worked extensively with the experienced team of medical writers at Certara to build a next-generation product for medical writers that fully incorporates the value of generative AI,” said Christopher Bouton, PhD, Senior Vice President, Artificial Intelligence, Certara. “With CoAuthor, medical writers can create consistent, reproducible content, improving the time to first draft by at least 30 percent. Our human-in-the-loop model significantly reduces drafting time, while still enabling writers to use the generated content in the ways that they decide is best.”