Medical Translation for Institutions & CROs

With expert knowledge of French and German medical terminology and a professional awareness of issues related to patient safety and reputational risk, Will Maitland is a specialist medical translator with more than 10 year's professional experience in the healthcare sector, providing accurate, certified translations that help deliver patient well-being.

The expansion of medical research, particularly clinical trials, across multiple countries is the most significant driver of document translation:

Patient Safety and Informed Consent

Documents such as informed consent forms (ICFs) and patient information sheets must be accurately translated from French and German into the English for potential participants. This ensures they fully understand the trial's procedures, risks, and benefits, upholding ethical standards and legal requirements for informed consent. Errors here can have dire, even life-threatening, consequences.

Recruitment and Retention

Providing culturally appropriate and clear materials in English builds trust and will be vital for successfully recruiting and retaining your patient population, which strengthens the validity of trial data.

Study Integrity

Core trial documentation, such as protocols, investigator brochures, and case report forms (CRFs) must be translated precisely and consistently for all international investigators and research staff to ensure the study is conducted uniformly across all sites.

Medical and pharmaceutical products are heavily regulated, and the authorities in English-speaking countries often mandate translations:

International Submissions

Documents submitted to regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) must be in the official language of the country where approval is sought. This includes regulatory filings, product dossiers (e.g., eCTD modules), and safety updates.

Audits and Inspections

All trial-related records must be available for audit in a clear, consistent, and compliant format, often requiring a documented, certified translation process.

Product Information

The translation of Summary of Product Characteristics (SmPCs), patient information leaflets (PILs), and medical device instructions for use (IFUs) is mandatory to ensure users and patients worldwide receive correct, safe dosage and usage instructions.

As a hospital and other direct care provider, you will require translation for essential operations:

Medical Records

Translating patient medical histories, discharge summaries, and diagnostic reports is necessary when your patients travel internationally or seek treatment abroad, ensuring continuity and quality of care.

Hospital Forms

Admission forms, patient rights notices, and billing or insurance claims need translating in order to communicate effectively with non-native speaking patients.

Clear communication is essential when working with global partners:

Scientific Dissemination

The translation of research papers, abstracts, and publications allows findings to be shared and peer-reviewed by the global scientific community.

Training Materials

Standard operating procedures (SOPs), training manuals, and educational resources must be translated for international staff, investigators, and local site teams to ensure they are adequately trained and follow procedure.