NARRATIVA · MEDICAL COAUTHORING

AI Agent for Regulatory Writing Translation

Extend medical writing across languages with AI-assisted translation informed by document context, approved terminology, and sponsor guidance—while medical.

MEDICAL COAUTHORING●●●
CLINICAL STUDY REPORT · SOURCEStudy treatment was generally well tolerated.
APPROVED TERMINOLOGYAdverse event · sponsor glossary✓
TRANSLATION DRAFTS
ESEl tratamiento del estudio fue generalmente bien tolerado.✓
FRLe traitement de l’étude a été généralement bien toléré.✓
DEDie Studienbehandlung wurde im Allgemeinen gut vertragen.✓

TRUSTED BY LIFE SCIENCES ORGANIZATIONS

REGULATORY WRITING · MEDICAL COAUTHORING

Translate. Review.
Keep the context.

Support multilingual regulatory content with document-aware translation, controlled terminology, and expert review in the medical writing process.

DOCUMENT & SPONSOR GUIDANCEClinical Study ReportStudy-specific language“adverse event”Use approved glossary term✓
01 / CONFIGURE

Bring the right context

Set the document type, source material, target language, sponsor instructions, and approved terminology for the translation task.

MEANING ACROSS LANGUAGESKeep the evidence clear.Clinical context informs the draft
CSRPROTOCOLIB
02 / TRANSLATE

Preserve document meaning

Generate a translation draft guided by the source, document context, and configured terminology—not just isolated sentences.

MEDICAL WRITER REVIEW
✓Terminology checked
✓Scientific meaning reviewed
↗Refine before use
03 / REVIEW

Keep experts in control

Medical writers and language experts review and refine translated content before it is approved for its intended use.

A CAPABILITY OF MEDICAL COAUTHORING

Multilingual writing, grounded in the document.

Clinical and regulatory documents carry study-specific language, structured content, and carefully defined meaning. Translating them calls for more than fluency: teams need the right source context, consistent terminology, and review by people who understand the document.

Regulatory Writing Translation brings generative AI translation into the Medical Coauthoring solution. Use document-specific instructions and glossaries to guide drafts for materials such as Clinical Study Reports, protocols, and Investigator Brochures, then keep medical writers central to review and refinement.

A clinical study report source connected to Spanish, French, and German translation drafts, guided by study context and sponsor terminology
BUILT FOR REGULATED CONTENT

Language aligned
with the science.

Help medical writing teams carry document meaning and approved terminology across multilingual content.

Study-specific terminology

Use configured glossaries and sponsor guidance to support consistent terms across translated content.

02

Document-aware drafts

Provide source material and document context to guide translation of scientific and regulatory writing.

03

Meaning before literal wording

Support clear, natural-language drafts while preserving the intended scientific meaning for expert review.

04

Multiple document types

Apply the workflow to clinical and regulatory content such as CSRs, protocols, and Investigator Brochures.

05

Medical-writer oversight

Keep writers and qualified language reviewers responsible for refining and approving translated content.

06

Part of Medical Coauthoring

Connect translation needs with the broader clinical document authoring and review process.

REGULATORY WRITING TRANSLATION · FAQ

Translation for clinical documents.

How AI-assisted translation fits into the Medical Coauthoring workflow.

What is Regulatory Writing Translation?

It is an AI-assisted translation capability for clinical and regulatory writing within Medical Coauthoring. It helps teams prepare multilingual drafts using source material, document context, configured terminology, and sponsor instructions.

How does it fit into Medical Coauthoring?

Translation complements clinical document authoring by supporting multilingual content alongside medical writing workflows. Medical writers remain involved in reviewing and refining the output for its intended use.

Which documents can teams translate?

Teams can apply the approach to clinical and regulatory content such as Clinical Study Reports, clinical trial protocols, Investigator Brochures, and other sponsor-defined documents.

How are approved terms and sponsor preferences handled?

Translation instructions can include custom glossaries, preferred terminology, and sponsor-specific guidance. These inputs help guide consistent wording in the generated draft and should be checked by reviewers.

Does AI translation replace medical or local-language review?

No. AI supports the translation process, but medical writers and appropriately qualified language reviewers remain responsible for assessing scientific accuracy, local requirements, and suitability for the intended use.

Does a translated draft mean a document is submission-ready?

A translated draft requires review against the relevant study, sponsor, and regional requirements before it is used or submitted. The workflow supports drafting; it does not replace sponsor approval or any required linguistic validation.

Need help exploring?

Narrativa SideKick AI Agent can help you discover solutions, success stories & more.

Talk to SideKick AI Agent