AI-enabled solutions accelerate regulatory and medical writing processes, enhancing quality, transparency, and efficiencies
RADNOR, PA – 2024年6月17日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) は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. ジェネレーティブAI、ドキュメント・テンプレート、Microsoft Wordとの統合、構造化コンテンツ・オーサリング・ツールを搭載しています。CoAuthor accelerates the creation of regulatory documents while maintaining a “human in the loop” approach to the use of generative AI.
メディカルライティングは医薬品開発において重要な役割を担っています。その執筆プロセスは過去20年間大きく変化しておらず、手作業に大きく依存しているのが現状です。医薬品開発パイプラインは、高度な生物医学的知識に依存する精密医療治療で構成されることが多くなってきています。今日のメディカルライターは、複雑な研究計画やデータをさまざまな読者に向けて研究結果を説明する文書に翻訳しなければなりません。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, Ph.D., 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, Ph.D., 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%. 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.”
To learn more about CoAuthor solutions for regulatory writing, join the Certara team at the DIA Annual Meeting in San Diego, CA at booth 2319. Additionally, Certara leaders Chris Bouton and Demetrius Carter, Senior Vice President, Regulatory Services, Certara, will present the new platform in an Innovation Theatre session, Technology-Enabled Writing – Use CoAuthor™ as your Fully Integrated GenAI Medical Writing Platform, on June 17th. More information about Certara’s presence at the DIA Annual Meeting is available here.
Certara（サターラ）について
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. 製薬、教育機関、規制当局のお客様 2,400人以上、6662ヵ国にてサターラの技術やサービスが活用されています。詳細は弊社ホームページをご覧ください。
お問合せ先
Sheila Rocchio
sheila.rocchio@certara.com
報道機関の皆様：
Alyssa Horowitz
certara@pancomm.com
