Clinical trials, regulatory submissions, patient information and medical device documentation by medically-trained translators.
Medical translation operates at a different standard to most other translation categories. An ambiguous term in a marketing brochure causes a misunderstanding. An ambiguous term in a clinical trial protocol or patient information leaflet can cause harm. The standards for accuracy, consistency and traceability are accordingly different.
Our medical translators have clinical or scientific backgrounds. They are not linguists who picked up medical terminology. They are qualified professionals who developed translation as a specialisation. This matters most when they encounter terminology that is used differently across national medical systems, or when source material contains technical ambiguities that a non-specialist would simply translate rather than flag.
We work with all the standard document types for pharmaceutical and medical device companies: clinical study reports, investigator brochures, informed consent forms, patient recruitment materials, device instructions for use, summary of product characteristics, and regulatory correspondence. We also handle academic medical journals and systematic reviews.
For regulatory submissions, we understand the specific requirements of the European Medicines Agency and Italian AIFA. Documents submitted for regulatory review must meet particular formatting and terminology standards. We build these requirements into the project from the start, not as a revision at the end.
"The EMA accepted our submission first time. The terminology was exactly right across all five language versions."
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