MEDICAL AUTHORING COMPANION · CUSTOMER STORY
A leading global biopharmaceutical company
Global biopharmaceutical company uses AI Agents to accelerate Clinical Trials documentation
How an AI-powered medical writing platform turns weeks of manual clinical documentation into regulatory-ready drafts in hours.
Company Global biopharmaceutical companyWork Clinical trial documentationSolution Medical Authoring Companion
THE RESULTSFrom weeks of work
From weeks of work
to drafts in hours.
Narrativa’s AI-powered platform helps clinical teams generate regulator-ready drafts faster, streamline approvals, and deliver treatments to patients sooner.
instead of weeks
supported
leadership
company’s reach
THE PROBLEM
Complex clinical data. A demanding submission timeline.
One of the leading biopharmaceutical companies globally is transforming its approach to clinical trial documentation through a partnership with Narrativa. The collaboration aims to streamline regulatory content creation, improve document quality, and reduce operational complexity.
Clinical trial documentation is among the most labor-intensive parts of drug development. Patient narratives, Clinical Study Reports (CSRs), and Tables, Listings, and Figures (TLFs) involve large volumes of structured data and painstaking manual work from medical writing teams.
Teams needed a way to turn clinical data into regulatory-ready documents faster, while maintaining accuracy, traceability, and each sponsor’s documentation standards.
THE SOLUTION
Connect clinical data to submission-ready content.
Narrativa’s Medical Authoring Companion combines AI agents with a proprietary Knowledge Graph and adapts to each sponsor’s standards to create accurate, traceable, regulator-ready content.
Structure study data
Bring extensive clinical data and source information into a connected authoring workflow.
Generate first drafts
Automate patient narratives, CSRs, TLFs, and redaction and anonymization work.
Focus writers on review
Give medical writers high-quality drafts so they can focus on quality control, final review, and strategic input.
THE KPIS
Operational improvements across the process.
Drafting speed
Initial clinical-document drafts can move from weeks of manual work to hours, accelerating the clinical trial timeline.
Lower risk
Automated data interpretation helps reduce human error and support regulatory compliance.
Cost efficiency
Fewer manual hours translate into leaner operations and reduced overhead.
Simpler operations
Automation can reduce stakeholder handoffs and simplify collaboration and version control.
THE OUTCOMEFaster documentation.
Faster documentation.
Earlier access to treatments.
Backed by more than 50 years of pharmaceutical leadership and a presence in over 50 countries, the company is focused on improving access to quality medicines. Its partnership with Narrativa supports R&D innovation and the goal of delivering treatments to patients faster, safer, and at lower cost.