Clinical Trial Translation Services

Specialist Clinical Trial Translation Services

Global clinical trials generate substantial volumes of documentation across multiple languages, regulatory frameworks and ethical requirements. From study protocols and informed consent forms to case report forms and regulatory submissions, every document carries both scientific and legal weight – and accurate, consistent translation is fundamental to trial integrity and participant safety.

Omnilingua has worked with CROs, pharmaceutical sponsors and biotech companies on clinical trial translation for over 25 years. Our translators specialise in clinical research documentation and are familiar with the regulatory environments in which trials operate, including EU Clinical Trial Regulation (CTR) and MHRA requirements. All translation work follows ICH-GCP guidelines as standard.

We work closely with clinical operations teams from the earliest stages of a project – agreeing terminology, mapping document workflows and building translation schedules that align with trial timelines. The result is translation that keeps pace with your study rather than holding it up.

Our Clinical Trial Translation Services

Clinical Documentation:

Study Protocol Translation – Full protocol and synopsis translation for regulatory and ethics submissions
Informed Consent Forms (ICF) – Plain-language, culturally appropriate translations for patient understanding
Patient Information Sheets (PIS) – Clear participant-facing materials meeting ethics committee standards
Case Report Forms (CRF) – Consistent, validated translations for accurate data capture
Investigator Brochures – Complete translation of investigational product dossiers

Regulatory & Submissions:

MHRA Submission Documents – UK regulatory authority filings and correspondence
EU CTR Submissions – European Clinical Trials Information System (CTIS) documentation
Ethics Committee Applications – IRB and ethics board submission packages
Clinical Study Reports (CSR) – ICH E3 compliant report translations
Risk Management & Safety Documentation – SUSAR reports and safety narratives

Clinical Trial Localisation Services

Patient-Facing Adaptation:

Plain-language review ensuring genuine participant comprehension
Cultural adaptation for participant recruitment materials
Readability assessment across literacy levels
Consistency of medical terminology with approved glossaries
Back-translation and reconciliation for validated instruments

Quality & Compliance:

ICH-GCP compliant translation workflows
Terminology management across all trial languages and sites
Version control for protocol amendments and document updates
Certificate of translation for regulatory submission
Audit-ready translation documentation

Working With Omnilingua on Clinical Trial Translation

Global clinical trials generate substantial volumes of documentation across multiple languages, regulatory frameworks and ethical requirements. From study protocols and informed consent forms to case report forms and regulatory submissions, every document carries both scientific and legal weight — and accurate, consistent translation is fundamental to trial integrity and participant safety.

Omnilingua has worked with CROs, pharmaceutical sponsors and biotech companies on medical translation for over 25 years. We work closely with clinical operations teams from the earliest stages of a project — agreeing terminology, mapping document workflows and building translation schedules that align with trial timelines.

Frequently Asked Questions: Clinical Trial Translation

What documents need to be translated for a clinical trial?

The core documents requiring translation include the study protocol and synopsis, informed consent forms, patient information sheets, case report forms, investigator brochures, and any ethics committee submission materials. For multi-country trials, recruitment advertising, patient diaries, and quality-of-life questionnaires will also typically require translation and sometimes linguistic validation. Regulatory submission documents for each country authority — such as MHRA in the UK or national competent authorities within the EU — will need translation into the relevant official language.

What does ICH-GCP compliant translation mean?

ICH-GCP (International Council for Harmonisation – Good Clinical Practice) is the international standard governing the design, conduct and documentation of clinical trials. Compliant translation means that documents are translated by qualified specialist translators, that terminology is verified and consistent, that translation processes are documented and auditable, and that the translation accurately reflects the intent of the source document without ambiguity. For informed consent documents in particular, GCP compliance requires that the translation enables genuine understanding – not merely a word-for-word rendering.

How do the 2025 MHRA reforms affect clinical trial translation in the UK?

The 2025 MHRA reforms introduced a combined MHRA/Ethics review with a 30-day approval clock. This means all participant-facing materials – including translated informed consent forms and patient information sheets – must be ready in final form before submission, not after. Translation can no longer run sequentially after protocol finalisation; it must run in parallel. Early engagement with your translation partner is now essential to meet the 150-day UK clinical trial set-up target.

What is the difference between translation and linguistic validation for clinical trials?

Translation converts a document from one language to another. Linguistic validation is a more rigorous process used specifically for patient-reported outcome (PRO) instruments, quality-of-life questionnaires and similar tools. It involves forward translation, back-translation, expert panel review, and cognitive debriefing with patients to confirm the translated instrument measures the same concept as the original. Omnilingua can advise on which approach is required for each document type in your trial.

Can you handle protocol amendments during a live trial?

Yes – managing amendments is one of the most operationally demanding aspects of clinical trial translation, and one we plan for from the start. We maintain version-controlled translation memories for every trial, so amendments can be processed efficiently with full consistency against previously approved terminology. We will also flag any downstream documents that may be affected by a protocol change. Read more about our terminology management.

How long does clinical trial translation take?

Timelines depend on document length, language combination, and technical complexity. An informed consent form in a single language can typically be turned around in two to three working days. A full study protocol across multiple languages will require more lead time and benefits from early planning. We work with your clinical operations team to build realistic translation schedules into your overall trial timeline from the outset. See our translation turnaround times page, or contact us for a project-specific assessment.