Specialist service
Clinical Trial Translation Services
Accurate, compliant translation for every stage of the clinical trial lifecycle — from protocol to patient, in over 220 languages.
What Is Clinical Trial Translation?
Clinical trial translation is the accurate, culturally appropriate rendering of trial-related documentation into the languages spoken by patients, investigators and regulators across every site in a multi-country study. It covers everything a trial produces — from the protocol that governs how the study is run, to the informed consent form a patient signs before enrolling, to the safety and efficacy data submitted to regulators once the trial concludes.
Because clinical trial documents directly affect patient understanding, patient safety and regulatory approval, translation errors are not a formatting inconvenience — they are a compliance and safety risk. At TranslationsInLondon, every clinical trial translation is carried out by qualified human linguists with subject-matter expertise in life sciences, following an ISO 17100-aligned translation, editing and proofreading (TEP) process. We do not use machine translation for clinical trial content.
For patient-facing instruments such as questionnaires, diaries and outcome measures that require formal linguistic and cultural equivalence testing, see our dedicated Linguistic Validation Services page.
Clinical Trial Documents We Translate
Document Type
Examples
Patient-Facing Documents
Informed Consent Forms (ICFs), Patient Information Sheets, patient diaries, recruitment materials, patient-reported outcome (PRO) instruments
Study Conduct Documents
Clinical trial protocols and amendments, case report forms (CRFs), investigator brochures (IBs), site operating procedures
Regulatory & Ethics Submissions
Ethics committee/IRB submission packages, regulatory correspondence, trial registration documents
Safety Documentation
Adverse event reports, safety narratives, pharmacovigilance correspondence (see Pharmacovigilance Translation Services)
Labelling & Packaging
Investigational medicinal product (IMP) labels, packaging inserts
Post-Trial Materials
Clinical study reports, lay summaries of results, publication manuscripts
Our Clinical Trial Translation Process
- Scoping & Terminology Setup — We review source documents, confirm target languages/locales, and build or apply a study-specific glossary and style guide to ensure consistency across every document and every language.
- Translation by Subject-Matter Linguists — Native-speaking translators with life sciences expertise translate the content, never machine translation.
- Independent Editing — A second qualified linguist reviews the translation against the source for accuracy, terminology consistency and register.
- Proofreading & QA — A final quality check confirms formatting, completeness and compliance with any client-specific style requirements.
Back-Translation (on request) — For informed consent forms and other high-sensitivity patient documents, we offer back-translation and reconciliation as an additional quality safeguard.
- Delivery & Certification — Documents are delivered in the required format, with a signed certificate of accuracy where needed for regulatory or ethics committee submission.
Why Sponsors and CROs Choose TranslationsInLondon
ISO 17100-aligned process — Every project follows a structured translate–edit–proofread workflow.
Human translation only — No machine translation is used on clinical trial content; every word is translated and checked by qualified linguists.
220+ languages — Coverage for multi-country, multi-site trials of any scale.
Life sciences specialists — Our linguist network includes translators experienced in pharmacovigilance, regulatory affairs and medical device documentation.
Linguistic validation partnership — For clinical outcome assessments (COAs), PROs and other instruments requiring formal validation, we work alongside our linguistic validation partners to deliver the full ISPOR-aligned methodology.
ITI Corporate Member — TIL is a Corporate Member of the Institute of Translation and Interpreting.
Confidentiality as standard — NDAs and secure file handling for every clinical trial engagement.
Frequently Asked Questions
Do you provide certified translations for regulatory or ethics committee submission?
Yes. We provide a signed certificate of accuracy with every clinical trial translation where one is required for submission.
Do you use machine translation for clinical trial documents?
No. All clinical trial translation at TIL is carried out by qualified human linguists. We do not use machine translation for this type of content.
What's the difference between translation and linguistic validation?
Standard translation is appropriate for most trial documentation (protocols, CRFs, IBs, regulatory correspondence). Linguistic validation is a more rigorous, multi-stage process — including forward translation, reconciliation, back-translation and cognitive debriefing — required for patient-facing outcome measures such as PROs, clinician-reported outcomes (ClinROs) and other clinical outcome assessments where conceptual equivalence must be demonstrated to regulators. See our Linguistic Validation Services page for details.
Can you handle a multi-country trial with many target languages at once?
Yes. We regularly manage projects spanning 10+ locales simultaneously, with a single point of contact coordinating terminology consistency across all languages.
How do you ensure terminology consistency across a long-running trial with multiple amendments?
We build and maintain a study-specific glossary and translation memory from the first document onward, so that terminology stays consistent across protocol amendments, subsequent documents and future phases of the same trial.
What languages do you cover?
We translate to and from 220+ languages. Get in touch with your target languages and we’ll confirm coverage and turnaround.
Ready to discuss your clinical trial translation needs?
Whether you’re preparing a single-country study or coordinating a multi-site global trial, our team can scope your translation and linguistic validation requirements and provide a clear quote.