Home/Medical Authoring Companion

NARRATIVA · MEDICAL AUTHORING

Medical Authoring Companion

AI agents that help clinical teams create, translate, and review accurate clinical and regulatory content—from Clinical Study Reports, protocols, and.

Talk to our team ↗

Medical Authoring Companion workspace with source-linked clinical content and review checks

AI AGENTS TRUSTED BY LIFE SCIENCES ORGANIZATIONS

A CONNECTED AUTHORING WORKFLOW

From study evidence
to review-ready.

Purpose-built agents work together across document authoring—bringing study context into the workflow, preparing structured drafts, and supporting quality review while medical writers guide the work.

Understand the document

Start with the document type, study requirements, and available source materials.

Connect the evidence

Bring relevant study data and supporting artifacts into context for the requested document.

Generate a structured draft

Coordinate specialized agents to organize content and prepare a first draft aligned to document requirements.

Review with confidence

Keep writers in control with source-linked content and support for consistency and quality checks.

MEDICAL AUTHORING USE CASES

End-to-end
authoring workflows.

Explore authoring workflows across clinical, nonclinical, quality and CMC, safety, and cross-functional use cases.

CLINICAL STUDY REPORT

Clinical Study Report

Transform clinical study data and Tables, Listings, and Figures into clear, structured CSR drafts with traceability to supporting evidence.

CLINICAL TRIAL PROTOCOL

Clinical Trial Protocol

Support protocol development from study synopsis to structured draft, with agents for study design, burden analysis, and compliance checks.

STATISTICAL ANALYSIS PLAN

Statistical Analysis Plan

Translate protocol objectives into prespecified analysis populations, endpoints, estimands, and statistical methods for expert biostatistics review.

INVESTIGATOR BROCHURE

Investigator Brochure

Bring clinical, nonclinical, and safety evidence into structured, traceable Investigator Brochure drafts that experts can review and update.

REGULATORY WRITING TRANSLATION

Regulatory writing translation

Prepare multilingual clinical and regulatory drafts guided by document context, approved terminology, and sponsor instructions—with medical writers in control of review.

SCIENTIFIC WHITEPAPER

Scientific Whitepaper

Generate scientifically grounded whitepapers from clinical data and validated sources, with claims linked to evidence for transparent review.

INFORMED CONSENT

Informed consent

Support clear, participant-centered consent drafts aligned to approved study information, with readability checks and expert review.

QUALITY OVERALL SUMMARY

Quality Overall Summary

Prepare source-linked CTD Module 2.3 drafts from quality evidence, with cross-document consistency checks and expert CMC review.

CMC SOURCE SECTIONS

Organize the detailed drug substance and drug product source sections behind the Quality Overall Summary, from manufacturing descriptions to specifications, stability reports, and analytical method validation.

CLINICAL OVERVIEW

Clinical Overview

Synthesize clinical pharmacology, efficacy, and safety findings into a source-grounded CTD Module 2.5 draft for expert critical assessment.

CLINICAL SUMMARY

Clinical Summary

Organize clinical pharmacology, efficacy, safety, and study findings into source-linked summaries that experts can verify and interpret.

PERIODIC SAFETY REPORT · PSUR / PBRER

Periodic Safety Report

Bring interval and cumulative safety evidence into structured PSUR/PBRER drafts for traceable, expert-led benefit–risk review.

NONCLINICAL OVERVIEW

Nonclinical Overview

Connect pharmacology, pharmacokinetics, and toxicology evidence in a traceable CTD Module 2.4 draft for expert scientific assessment.

DEVELOPMENT SAFETY UPDATE REPORT · DSUR

Development Safety Update Report

Organize annual clinical-trial safety findings and cumulative exposure into traceable DSUR drafts for qualified review.

NONCLINICAL STUDY REPORT

Nonclinical Study Report

Turn pharmacology, pharmacokinetics, and toxicology study data into structured reports with linked findings for scientific review.

NONCLINICAL WRITTEN AND TABULATED SUMMARY

Nonclinical Written and Tabulated Summary

Structure nonclinical study evidence into source-linked CTD Module 2.6 narratives and tables for expert interpretation.

REGULATORY CONTENT VALIDATION

Regulatory Content Validation

Check regulatory content against approved evidence, surface inconsistencies and missing information, and route findings to qualified reviewers.

MEDICAL AUTHORING COMPANION · FAQ

About medical authoring.

Learn how the Medical Authoring Companion supports clinical document and translation workflows.

What is the Medical Authoring Companion?

The Medical Authoring Companion is a network of purpose-built AI agents that helps life sciences teams create, translate, and review clinical and regulatory content, with medical writers guiding the workflow.

Which workflows are featured?

The Medical Authoring Companion supports the Investigator Brochure, clinical trial protocol, Statistical Analysis Plan, informed consent, Clinical Study Report, Clinical Summary, CTD Module 3 CMC authoring, Quality Overall Summary, Clinical Overview, Nonclinical Overview, Nonclinical Study Report, Nonclinical Written and Tabulated Summary, periodic safety report (PSUR/PBRER), Development Safety Update Report (DSUR), scientific whitepaper, and regulatory writing translation. Each workflow uses agents guided by source materials, document structure, and audience needs.

How do medical writers stay in control?

AI agents support drafting and quality checks while medical writers and subject-matter experts remain central to review, refinement, scientific interpretation, and approval.