Certara Launches Next Generation CoAuthor™ Generative AI Regulatory Writing Software
Certara (Nasdaq: CERT) has launched its next-generation CoAuthor regulatory writing software, enhancing the medical writing process using generative AI. Unveiled on June 17, 2024, CoAuthor integrates AI, document templates, and Microsoft Word, aiming to expedite the creation of regulatory documents while maintaining a 'human in the loop' approach. The software allows medical writers to efficiently synthesize complex biomedical data, providing a secure and specialized GPT for the drug development sector.
The platform promises to improve drafting times by at least 30%, enhancing content curation and quality control. Certara’s CEO, William Feehery, emphasized the company's expertise in maximizing AI’s potential in drug development. CoAuthor will be presented at the DIA Annual Meeting in San Diego, featuring a dedicated session on June 17th.
- Launch of CoAuthor software integrating generative AI and structured content authoring tools.
- Improves drafting time for regulatory documents by at least 30%.
- Offers secure, client-specific GPT specialized for life sciences.
- Enhances content curation, collaboration, and quality control.
- Fully integrated with Microsoft Word, ensuring familiarity and ease of use for writing teams.
- Flexibility for clients to use CoAuthor at program levels and across enterprises.
- Certara’s proven expertise in AI and drug development highlighted.
- No specific financial performance metrics or revenue projections provided for CoAuthor.
- Potential risk if the AI does not perform as expected in real-world scenarios.
- Unclear how quickly the market will adopt the new software.
Insights
The introduction of Certara's CoAuthor represents a significant technological advancement in regulatory writing within the pharmaceutical industry. Leveraging generative AI to streamline the creation of regulatory documents offers a critical boost in efficiency and quality control. Generative AI can process vast amounts of data and produce draft documents faster than traditional methods, which can be especially beneficial in drug development where timelines are tight and precision is paramount.
By incorporating a 'human-in-the-loop' approach, Certara ensures that while AI handles repetitive tasks, medical writers retain control over the content, maintaining the quality and context required for regulatory compliance. This combination of AI with human oversight could significantly reduce the time to first draft by at least 30%, as stated, which translates to swifter progress in drug approval processes and potential cost savings.
Moreover, the integration with Microsoft Word allows for a seamless transition for users, mitigating the learning curve and encouraging adoption. Overall, this innovation could establish a new standard in regulatory writing, promoting greater efficiency and consistency.
From a medical research perspective, the integration of AI in regulatory writing addresses several challenges that have long plagued the industry. Traditional medical writing is labor-intensive and prone to human error. CoAuthor's generative AI capabilities can help mitigate these issues by ensuring accuracy and consistency in documentation.
Furthermore, as drug development becomes more complex with the rise of precision medicine, having a tool that can handle and synthesize intricate biomedical data into coherent documents is invaluable. This can enhance the clarity of research findings when presented to regulatory bodies, potentially smoothing the approval process for new therapies.
Additionally, the platform's ability to handle eCTD (electronic Common Technical Document) templates ensures that documents are compliant with international regulatory standards, which is important for global submissions. This aspect is particularly important for companies seeking approval across multiple regions, reducing the administrative burden and expediting the regulatory review process.
AI-enabled solutions accelerate regulatory and medical writing processes, enhancing quality, transparency, and efficiencies
RADNOR, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- 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, Microsoft 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, 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
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.
About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. Learn more at certara.com.
Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
certara@pancomm.com
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