CoAuthor™ is Certara’s innovative GenAI software for regulatory and medical writing, designed to streamline the drafting of regulatory documents. By leveraging a leading-edge GPT, a comprehensive eCTD template library, and structured content authoring, CoAuthor empowers regulatory writing teams to focus on contextualizing data and developing key messages. With built-in transparency, consistency, and collaboration tools, CoAuthor reduces submission timelines, enabling faster access to life-saving medicines for patients.
CoAuthor
Meet your team’s newest regulatory writing assistant
Discover how CoAuthor can transform your regulatory and medical writing processes.
Extends your favorite writing application, Microsoft Word
More than 275 eCTD templates at your fingertips
Summarize text and data with a click
Collaborate with other writers in real-time
Save up to 40% in efficiency gains
Transforming regulatory writing with CoAuthor
CoAuthor simplifies the complexities of regulatory writing by integrating a purpose-built biomedical GPT, structured content, and eCTD templates directly into Microsoft Word. This specialized GenAI software for medical writing ensures secure, organization-specific use, eliminating data leakage risks and enhancing document quality.
- Generate documents such as patient narratives, clinical study reports, and protocols with ease
- Leverage structured content authoring for content reuse and consistency
- Automate formatting, hyperlinking, and metadata population for efficiency
Write less, analyze more
Consistency within and across study documents
With a permissions-governed repository of structured content, you can be assured that study identifiers, chemical formulas, mechanisms of action, and any other “verbatim” content remains consistent
Human-at-the-helm AI
CoAuthor’s GPT, built on proprietary retrieval-augmented generation (RAG) architecture, references only the source data and text you allow, ensuring accuracy and direct referencing. Run, rerun, and refine text and data summaries in real-time, knowing that your data and prompts are 100% private to your organization.
There’s a (customizable) template for that
Select from any of more than 275 eCTD templates and customize them with your organization’s standards.
Related products and services
CoAuthor unites all the features missing from off-the-shelf text AI and other regulatory tools
Regulatory document template suite
Structured content authoring
Regulatory-specific Generative AI
Auto styling & hyperlinking
Traceability & version control
Real time preview
Collaborative authoring & review
Meta-data & document repository
Off the shelf prompt library
MS Word integration
Regulatory document repository
Tech-enabled medical writing services
Your partner in regulatory excellence
Certara stands at the forefront of both life science-specialized GenAI and regulatory expertise. CoAuthor was developed by writers, for writers, in conjunction with a team ready to partner with you on training your staff of experts.
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Your data is safe with CoAuthor
At Certara, we understand the paramount importance of protecting your information. That’s why we are proud to hold an ISO 27001 certification for Certara’s Information Security Management System (ISMS). With ISO 27001, you can have peace of mind knowing that we have implemented robust security controls, undergone rigorous risk assessments, and continuously strive for improvement.
Experience the future of regulatory writing with CoAuthor
Book a no-obligation demo to see how CoAuthor can revolutionize your regulatory writing processes.
Accelerate submission timelines with generative AI
Ensure compliance and consistency with built-in QA tools
Leverage secure, organization-specific AI for peace of mind
FAQs
What types of documents can CoAuthor generate?
CoAuthor can be used to create patient narratives, clinical study reports, protocols, synopsis, toxicology reports, and other clinical document
How does CoAuthor ensure data security?
CoAuthor is delivered as a secure, organization-specific model, eliminating risks of data leakage or exposure to public tools.
Can CoAuthor integrate with existing workflows?
Yes, CoAuthor integrates seamlessly with Microsoft Word and supports structured content authoring for streamlined workflows.
