Clinical Trial Translation Services
Our clinical trial translation services help sponsors, CROs, and research teams translate clinical study documents into multiple languages for every country. This includes informed consent forms, protocols, investigator brochures, case report forms, and patient questionnaires. Professional medical translators with a background in clinical research translate each document, a second medical linguist revises it, and one study glossary keeps terms consistent across all documents and languages.
clinical trial translation at a glance
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What we translate |
ICFs, protocols, investigator brochures, CRFs, COAs and PROs, safety reports and clinical study reports |
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Specialists |
Native medical translators with clinical research experience, plus a second medical reviewer |
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Requirements |
Plain-language consents, one glossary per study, version control for amendments, back translation on request |
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Files & platforms |
Word, PDF, Excel and XLIFF exports |
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Turnaround |
12,000 words/day · urgent amendments go first |
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Price |
From $0.08 / word · translation + revision |
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Delivered with |
A study glossary; back translation and certificate of accuracy on request |
About the service
What is clinical trial translation?
Clinical trial translation, also called clinical research translation, is about translating every document a study needs to run in another country that speaks a different language. This spans from the protocol and the investigator brochure to the consent form a participant signs. Each document has a different reader: regulators and ethics committees, site staff, and patients with no medical training.
That is why one translation style guide is not always a good fit for the whole study. A protocol needs exact medical terms, while a consent form must be clear enough for a study participant to understand the risks before signing. We use the right terms for each document, keep one glossary for the whole study, and track every amendment so all sites work from the same version.
Medical vs. Clinical trial translation →Who we translate clinical trial documents for
- Pharma and biotech sponsorsMulti-country studies from phase I to phase IV
- CROs Study start-up, site documents and amendments for sponsor clients
- Medical device companies Clinical investigations, IFUs and patient materials
- Academic and hospital research teamsInvestigator-led studies and ethics submissions
- Patient recruitment agencies Recruitment ads, study websites and screening scripts
What we translate
Clinical trial documents we translate
From study start-up to the final clinical study report, including the patient-facing text that ethics committees read most closely.
Study start-up and regulatory
- Protocols and protocol synopses
- Investigator brochures
- Ethics committee and IRB submissions
- Clinical trial agreements
Patient-facing documents
- Informed consent and assent forms
- Patient information sheets
- Recruitment ads and screening scripts
- Patient diaries and instructions
Safety and reporting
- Adverse event and SAE reports
- SUSARs and DSURs
- Clinical study reports (CSRs)
- Labels and IFUs for trial products
Data and outcomes
- Case report forms (CRFs and eCRFs)
- COAs, PROs and questionnaires
- eCOA and ePRO screens
- Lab and pathology reports
Accuracy + approval
What a translated trial document needs to get approved
A translation only helps your study if ethics committees approve it, sites find it useful, and participants understand it.
Consent forms participants understand
Ethics committees and IRBs reject consent forms that patients can't follow. We keep translated ICFs at the reading level of the source, explain medical terms in plain words, and keep every required element: procedures, risks, rights and contacts.
Usually needed for: ICFs, patient information sheets
Amendments without version mix-ups
Protocols and consents change during a study. We translate only what changed, track each version by number and date, and update every language at once, so no site works from an old version.
Usually needed for: Long multi-country studies
One glossary for the whole study
Drug names, endpoints, visit names, and adverse event terms stay the same in the protocol, the CRF, and the consent. We build the glossary at study start-up, follow MedDRA terms where your study uses them, and share it with your team.
Usually needed for: Protocols, CRFs, safety reports
Back translation when it's required
Some ethics committees and sponsors want proof that a consent or questionnaire means the same in both languages. An independent translator translates it back into English, and we reconcile any differences before you submit.
Usually needed for: ICFs, questionnaires, COAs
More detail: How to translate medical documents →
Need clinical trial translation services?
Send your files or details and get a fixed price and delivery date within 24 hours.
How we work
How your trial documents are translated
- 01Study set-up We review the documents, countries, and languages, set up the study glossary and version log, and send a fixed quote within 24 hours.
- 02Medical translation Native medical translators with clinical research experience translate each document in the right register for its reader.
- 03 Second medical review A second medical linguist checks terms, doses, numbers, and every required consent element against the source.
- 04Back translation and delivery If required, an independent translator back-translates, and we reconcile the differences, then deliver files formatted for submission.
Confidential by default
Linguists sign NDAs and files move over secure transfer.
Human translation
No AI translation unless you ask for it.
ISO 17100 process
Translation, revision and final checks on every job.
Pricing and turnaround
How much does clinical trial translation cost?
- Translation + revision
- from $0.08 / word
- Back translation and reconciliation
- Quoted per document
- Typical turnaround
- 12,000 words/day
- Urgent amendments
- Rush delivery +25%
- Quote and schedule
- Within 24 hours
Included in every price
- Native translator who specialises in your subject
- Full revision by a second linguist (ISO 17100)
- Your glossary and terminology kept consistent
- Formatting matched to your original file
- Confidential handling, NDA on request
- Fixed price before we start. No surprises.
Certified translations also include a signed statement of accuracy on our letterhead.
Fixed quote within 24 hours. No obligation.
What affects the price
- Repeated text. Sections repeated across consent versions and site documents are charged less.
- Amendments. Translation memory means only the changed text is translated and charged.
- Back translation. Adds a second, independent translation step where your ethics committee requires it.
- Number of countries. One glossary and set-up serve every language in the study.
- Source format. Editable Word or XLIFF files cost less than scanned PDFs.
Optional extras
- Rush delivery
- +25%
- Desktop publishing (InDesign, PDF)
- Per page
- Notarization or apostille
- On request
- Printed hard copy by courier
- On request
“We use Translation Partner for a broad range of services including label translations, proofreading and also document translations. The service has always been handled professionally and in a timely manner.”
Regulatory Affairs SpecialistFoster Clark
clinical trial translation questions
How much does clinical trial translation cost?
The clinical trial translation cost starts at $0.08 per word. The rate depends on the language pair, volume, and your deadline, and you get a fixed quote within 24 hours.
Which clinical trial documents do you translate?
Protocols, investigator brochures, informed consent forms, patient information sheets, CRFs, COAs and PROs, safety reports and clinical study reports, plus recruitment materials and clinical trial agreements.
Do you provide back translation?
Yes. When an ethics committee or sponsor requires it, an independent translator translates the document back into English, and we reconcile and record any differences in a report.
Who translates our trial documents?
Native medical translators with a background in clinical research, with a second medical linguist revising every file. We don’t use AI translation for trial documents unless you ask for it.
How do you handle protocol amendments?
We translate only what changed using translation memory, track each version by number and date, and update all languages together. Urgent amendments and safety letters go first, with rush delivery at +25%.
How do you keep consent forms readable for participants?
We consider the reading level of the source, explain medical terms in plain words so study participants can understand them, and keep every required element of the consent. A second linguist checks that a participant with no medical training can follow it.
How do you protect study and patient data?
Translators sign NDAs, files move over secure transfer, and only the assigned team sees them. Send de-identified data where possible, and we delete files after delivery if you ask.
Can you translate for many countries at once?
Yes. One glossary and style guide can serve every language, so a multi-country study uses the same terms everywhere. Our team translates about 12,000 words per day, and large studies are delivered in batches, priority countries first.
Want your clinical trial translation quote?
Send your files or details and get a fixed price and delivery date within 24 hours.
Complete the below form to get your quote