CoAuthor
Life Science Specialized GenAI for Regulatory Writing
Reduce submission timelines by leveraging the power of AI and automation to streamline document production
Using the right technology enables Regulatory Writers to focus their time and effort on key analysis, relevant messaging, and compliant regulatory documents. Regulatory writing teams are under pressure to reduce submission timelines – while facing resource shortages to support these demands. CoAuthor™ provides transparency, consistency, and collaboration to allow regulatory writing teams to accelerate the drafting and submission of quality and compliant regulatory documents, reducing timelines.
CoAuthor Empowers Regulatory Writing Teams
The software can be used to generate patient narratives, clinical study reports, protocols, and other clinical documents.
Focus on data interpretation and key message development
Say the same thing, in the same way, each time and each place across many documents
Streamline key decision points
Focus on data interpretation and key message development
Increased output with reduced time and cost
Streamline your authoring and review process to meet expedited timelines
The Trusted Choice for Regulatory Writing Groups Worldwide
Leverage real-time previews for built-in QA review
“The fact we could produce the first drafts so quickly was a key benefit for our timeline. And the fact that the quality control review was built in was an additional factor that contributed significantly to meeting our timeline goal.”
– Editor, Medical Writing, Leading biotech company
Reduce submission timelines through faster document creation
“When you think about the regulatory process from a patient’s perspective, the faster we can get a submission prepared and submitted, the faster that submission gets approved, and the faster patients have access to that medicine or whatever the health care solution is.”
– Heather Graham, Vice President – Regulatory Writing & Scientific Publications, Certara
Specialized Generative AI Accessed Directly in Microsoft Word
Generative AI is revolutionizing how regulatory writers approach the first draft of submissions. Leveraging the expertise of Certara.AI, CoAuthor features a specialized GPT to accelerate the drafting of documents. Delivered as a secure, organization-specific model, writers can confidently leverage generative AI without risk of data leakage or exposing their data to public tools. Understanding the needs for transparency and quality of GPT outputs, CoAuthor features a proprietary retrieval augmented generation (RAG) based architecture which significantly reduces hallucinations and provides referencing to source material for simplified QC of documents.
Format Less, Analyze More
Significant time and resources are wasted on data integration and formatting. CoAuthor’s suite of smart authoring tools allow you to spend less time formatting and more time interpreting your data.
- Integrate data directly into a document to ensure consistency and traceability
- Generate compliant e-templates which auto-populate content and metadata
- Leverage Structured Content Authoring (SCA) to maximize content referencing and reuse
- Automatically extract study attributes with AI Apply auto-styling to eliminate inconsistencies and build continuity throughout
- Automate hyperlinking throughout to eliminate steps and allow writers to write
CoAuthor: The Generative AI-Enabled Regulatory Writing Platform
Certara’s CoAuthor™, Generative AI-Enabled Regulatory Writing Platform, provides transparency, consistency, and collaboration to allow regulatory writing teams to accelerate the drafting and submission of quality and compliant regulatory documents.
| Feature | CoAuthor | Microsoft Copilot | Other Regulatory Tools |
|---|---|---|---|
| Regulatory Document Template Suite | X | ||
| Structured Content Authoring | X | X | |
| Regulatory-specific Generative AI | X | X | |
| Auto Styling & Hyperlinking | X | ||
| Traceability & Version Control | X | X | |
| Real Time Preview | X | X | |
| Collaborative Authoring & Review | X | X | |
| Meta-Data & Document Repository | X | ||
| Automated De-identification | X | ||
| MS Word Integration | X | X | |
| Regulatory Document Repository | X | ||
| Tech-enabled medical writing services | X |
Transparent, Consistent Project Management
The submission lifecycle requires managing numerous data sources, document drafts, and settings. CoAuthor streamlines project administration to provide transparency and consistency throughout submission development
- Enable consistent formatting and structured content authoring through a suite of over 275 eCTD templates along with the ability for uploading sponsor-created templates
- Secure repository allows for the management of all relevant documents and datasets as well as tables, listings, and figures
- Prompt library provides best practices for generative AI use for quality, desired outputs
- User access controls ensures only credentialed individuals gain access to project data and document drafts
Supercharge Your Regulatory Writing Team
Managing regulatory writing projects with moving timelines is challenging. Combine CoAuthor with Certara’s regulatory services team for a comprehensive, technology-driven partnership where we’ll work alongside your team to ensure quality, compliant and on-time submissions.
- CMC and Nonclinical Writing
- Safety and Annual Reports
- Clinical Submission Writing
- Biostatistics and Programming
- Study Level Documentation
- Document Publishing
Get a free demo of CoAuthor
Complete the form to book your no-obligation demo of CoAuthor… and see how better off you could be!
