Types of Medical Documents for Translation
In our practice we work with all categories of medical documentation:
- Regulatory documents — registration dossiers (CTD/eCTD), clinical study protocols, investigator's brochures (IB), informed consent forms (ICF)
- Clinical documentation — medical certificates, discharge summaries, test results, physician reports
- Pharmaceutical documentation — summaries of product characteristics (SmPC/PIL), GMP specifications, validation reports, registration dossiers
- Scientific literature — articles for peer-reviewed journals, conference abstracts, systematic reviews
- Medical devices — equipment manuals, technical files for CE marking, IFU (Instructions for Use)
Terminology Requirements
Medical translation requires command of several terminology systems:
- ICD-10/ICD-11 — International Classification of Diseases. Each diagnosis has an approved translation. Using an unofficial translation is grounds for document rejection.
- INN — International Nonproprietary Names for medicines. Brand names are not translated; INNs are taken from the official WHO registry.
- MedDRA — Medical Dictionary for Regulatory Activities. Mandatory for translating safety and adverse event reports.
- SNOMED CT — clinical terminology system used in electronic health records.
Our translators use current versions of terminology databases. A glossary is compiled for each project and agreed upon with the client.
GMP and GCP: Translation Specifics
GMP (Good Manufacturing Practice) — rules of proper manufacturing practice. GMP documentation translation is required for pharmaceutical facility registration and medicine import. The translator must know GMP document structure: SOPs (Standard Operating Procedures), validation protocols, specifications.
GCP (Good Clinical Practice) — rules of proper clinical practice. Translation of clinical study protocols, informed consent forms, and CRFs (Case Report Forms) is performed in strict accordance with ICH E6(R2). An error in protocol translation can lead to suspension of a clinical trial.
CAT Tools in Medical Translation
Medical translation is one of the areas where CAT tools deliver maximum impact:
- Translation Memory — regulatory documents contain 30–60% recurring segments (standard CTD sections, fixed ICF wording). TM stores all previous translations and ensures consistency when documentation is updated.
- Termbases — integrated glossaries check every segment against approved terminology. If a translator uses an unapproved term, the system alerts them.
- QA checks — automated verification of numbers (dosages!), units of measurement, formatting tags, missing segments.
We work in SDL Trados Studio and memoQ. For large pharmaceutical projects we use server solutions (Trados GroupShare, memoQ Server) for multiple translators to collaborate with a shared TM.
Pricing and Timelines
Medical translation costs more than standard due to translator qualification requirements and additional checks:
- Medical certificates and discharge summaries — from 850 RUB/page
- Registration dossiers (CTD) — from 1,150 RUB/page
- Clinical study protocols — from 1,250 RUB/page
- Summary of Product Characteristics (SmPC) — from 1,050 RUB/page
1 page = 1,800 characters with spaces of translated text. Standard rate: 5–8 pages per day. All translations follow the TEP cycle (translation, editing, proofreading) per ISO 17100.
Confidentiality
Medical documentation contains patient personal data and pharmaceutical company trade secrets. We sign an NDA for every project; all translators are trained in handling confidential information. Files are stored on secure servers and deleted 90 days after project completion (unless otherwise agreed).
Over 13 years we have translated more than 50,000 pages of medical documentation for pharmaceutical companies, clinics, and CROs. Request a quote — we respond within one hour.
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