CoAuthor is Certara’s GenAI-powered platform designed to streamline regulatory and medical writing. This guide defines key AI terminology and concepts as they apply specifically to CoAuthor, helping users understand the technology behind the tool and how to use it effectively.
Core AI Concepts in CoAuthor
Generative AI (GenAI)
AI that creates new content—text, summaries, or documents—based on input data. CoAuthor uses GenAI to draft regulatory documents like CSRs, patient narratives, and protocols.GPT (Generative Pre-trained Transformer)
The underlying language model powering CoAuthor. Unlike general-purpose GPTs, CoAuthor uses a biomedical-specialized GPT tailored for life sciences.Retrieval-Augmented Generation (RAG)
A technique that combines GPT with a retrieval system to ensure generated content is grounded in approved source documents. CoAuthor’s RAG architecture ensures accuracy and traceability.
How RAG Data Is Handled
When CoAuthor generates content, it retrieves relevant passages from your uploaded source documents and converts them into embeddings (vector representations) used to ground the AI's output. These embeddings — along with the source excerpts, prompts, and generated content associated with them — are treated with the same level of security and access control as your other project data. They are stored within your CoAuthor environment, scoped to the Sponsor and Project they were created under, and are deleted when the associated project or source document is deleted.
Human-in-the-Loop AI
CoAuthor supports collaborative authoring where AI assists but does not replace human judgment. Writers refine and validate AI-generated content within their workflow.
Document & Content Features
Structured Content Authoring
Enables reuse of validated content blocks (e.g., study identifiers, mechanisms of action) across documents for consistency and efficiency.Embedded Prompts
Pre-configured instructions within templates that guide the AI to generate specific sections of documents. These prompts are editable and customizable.Template Ingestion
CoAuthor can ingest existing document templates and overlay them with embedded prompts to automate content generation.eCTD Templates
CoAuthor includes over 275 global and regional templates compliant with electronic Common Technical Document (eCTD) standards.
Efficiency & Accuracy Tools
TLF Accuracy
CoAuthor automates the summarization of Tables, Listings, and Figures (TLFs), improving accuracy and reducing manual effort.
Version Control & Traceability
Every generated section is linked to its source, allowing users to validate and trace back the origin of AI-generated content.Real-Time Preview
Users can view and refine AI-generated content instantly within Microsoft Word, maintaining full control over the output.
Security & Compliance
Organization-Specific GPT
CoAuthor’s AI model is deployed securely within each organization, ensuring data privacy and eliminating risks of public data exposure.ISO 27001 Certification
Certara’s Information Security Management System ensures CoAuthor complies with global data protection standards.
Workflow Integration
Microsoft Word Plug-in
CoAuthor integrates directly into Word, allowing users to generate, edit, and validate content without leaving their familiar environment.Source File Compatibility
Supports multiple formats including.docx,.rtf,.csv,.pdf,.sas7bdat, and more.
Common Terms Summary
Term | Definition |
GenAI | AI that generates new content |
GPT | Language model used for text generation |
RAG | Retrieval-Augmented Generation for grounded outputs |
Structured Content | Reusable validated text blocks |
Embedded Prompts | Pre-set instructions for AI generation |
TLF | Tables, Listings, and Figures |
eCTD | Electronic Common Technical Document |
Human-in-the-Loop | AI-assisted writing with human validation |