MEDICAL AUTHORING COMPANION · CUSTOMER STORY
An Asian pharmaceutical company
Bringing clinical evidence together for CSR authoring.
An anonymized case study on organizing complex clinical study data into structured, review-ready Clinical Study Report drafts.
Company Asian pharmaceutical companyWork Clinical Study ReportsSolution Medical Authoring Companion
WORKFLOW FOCUSA clearer path from data
A clearer path from data
to clinical report.
The workflow is designed to bring study evidence, structured report sections, and expert review into one connected CSR authoring process.
evidence
content
sections
and approval
THE PROBLEM
Extensive study data. A demanding CSR lifecycle.
Clinical Study Reports bring together study design, methods, results, safety findings, and interpretation in a detailed regulatory document. Producing a complete report requires coordination across large datasets and source documents.
For this anonymized Asian pharmaceutical company, medical writing teams needed a clearer way to organize evidence and draft consistent report sections while preserving the scientific context behind each conclusion.
Manual extraction and drafting can make it difficult to keep content aligned across sections and trace statements back to the underlying study evidence.
THE SOLUTION
Connect source evidence to review-ready CSR drafts.
Narrativa’s Medical Authoring Companion supports report planning and drafting with AI agents that organize clinical inputs into a structured document workflow. Medical writers retain responsibility for interpretation, review, and approval.
Gather study evidence
Bring relevant clinical data and supporting source documents into the authoring workflow.
Draft report sections
Use AI agents to shape structured content in line with CSR organization and sponsor standards.
Verify and approve
Let medical writers trace claims to evidence, refine the science, and approve the final report.
THE KPIS
Measures for a more connected CSR workflow.
Drafting cycle time
Track the time from availability of study inputs to a complete initial CSR draft.
Source traceability
Review how readily report statements can be checked against the supporting clinical evidence.
Section consistency
Assess alignment of terminology, data, and conclusions across report sections.
Review effort
Monitor writer time spent reconciling sources, editing drafts, and completing quality review.
THE OUTCOME
A repeatable, source-connected report workflow.
The AI-assisted workflow is designed to help medical writers move from dispersed study inputs to organized CSR drafts with clearer source connections. Clinical experts remain in control of scientific interpretation, quality review, and approval.