Medical translation is a patient safety issue
A mistranslated dosage instruction in a package insert affects patients. An imprecise rendering of an adverse event definition in a clinical protocol affects the integrity of a trial. An error in an IFU document for a medical device affects the safety of the clinicians and patients who use it. These are not abstract risks.
Our medical and clinical translators are not generalists who learned medical terminology from reference books. They are nurses, pharmacists, clinical researchers, biomedical engineers, and healthcare professionals who became translators after careers in their clinical fields. They have worked in hospitals, laboratory settings, clinical research organizations, and pharmaceutical companies.
For FDA regulatory submissions and other US-specific compliance requirements, we are familiar with the applicable guidance documents and produce translations that meet the format and language requirements expected by reviewers.
Clinical and medical document types we handle
We cover the full range of clinical and healthcare documentation:
- Clinical trials: protocols, investigator brochures, study reports, ICF forms, CRFs (ICH E6, E3, E8 compliant)
- Regulatory: IND applications, NDA/BLA dossiers, post-marketing safety reports
- Pharmaceutical labeling: package inserts, prescribing information, patient information leaflets
- Medical devices: Instructions for Use (IFU), technical files, 510(k) submissions, de novo requests
- Medical records: discharge summaries, operative notes, radiology reports, pathology reports
- Patient communications: informed consent forms, patient education materials, survey instruments
- Scientific publications: research papers, conference abstracts, systematic reviews
- Healthcare policy: clinical guidelines, treatment protocols, standard operating procedures
- Health technology assessment: pharmacoeconomic models, HTA dossiers, payer submissions
Regulatory standards and compliance
FDA guidance documents (including 21 CFR Parts 11 and 314) have specific requirements for translated documents submitted in regulatory filings. We produce translations that comply with these requirements and use terminology consistent with FDA-approved labeling wherever applicable.
For patient-facing documents such as informed consent forms and patient information leaflets, we apply additional review to ensure that translated text meets FDA's requirements for readability and comprehension at an appropriate reading level. We also advise on back-translation requirements where applicable to your submission.
Our medical translation workflow includes a mandatory subject matter specialist review at the editing stage, separate from the initial translation and the final proofreading. This three-person quality assurance structure is the industry standard for high-stakes clinical documentation.