ICH GCP Aligned

Clinical Trial Translation Services

Clinical trial translation for sponsors, CROs and sites: protocols, consent forms and outcome assessments.

Years Experience

50,000+

Documents Translated

Get an instant quote 0800 193 8888

Why Lingo Service

ISO 17100 certified and an ITI corporate member
260+ languages, native qualified linguists
Certified translation from £35, transparent pricing
Same-day return available on weekdays
GDPR-compliant, files stored in the UK

Trustpilot TrustScore 4.6 · 46 reviews

What we do

What we translate for clinical teams

Protocols & Amendments

Study protocols, amendment deltas, investigator brochures, translated against versioned memory so every language stays in step

Consent & Patient Materials

Informed consent forms, participant information sheets, assent forms, diaries and apps, written at true lay reading level

COA & PRO Linguistic Validation

Dual forward translation, back translation, clinician review and cognitive debriefing to recognised good practice

Site & Ethics Documents

Ethics committee packs, site contracts, training materials, correspondence in both directions

Safety Communications

Urgent safety measures, SUSAR letters, dear investigator communications, same-day across all study languages

Lay Summaries & Results

Plain-language trial result summaries per locale, clinical study report sections, publication support

Every document class in a study

A single international trial generates translation work in at least a dozen distinct document classes, and treating them identically is how errors and overspend both happen. Each class has its own audience, register and quality requirement.

Core study documents

Protocol and amendments: the scientific reference document, translated for sites, ethics committees and regulators that require it
Investigator brochure: dense scientific prose for site staff
Informed consent forms and participant information sheets: legally significant and readability-critical, covered in detail below
Case report forms, eCRF screens and completion guidelines: where wording drives data quality
Patient diaries, apps and reminder materials: lay register, device constraints on text length

Operational and safety documents

Site contracts and budgets: legal register, handled with our legal translation practice
Ethics committee correspondence in both directions
Safety communications: SUSAR notifications, urgent safety measures, dear investigator letters, where turnaround is measured in hours
Development safety update reports and periodic safety documents
Lay summaries of results, now an expectation for trials under the EU Clinical Trials Regulation, written in genuinely plain language per locale

We assign each class the right treatment: certified translation with signed statements where a committee requires evidence, standard specialist translation where it does not, and linguistic validation where an instrument measures an endpoint. You are never paying validation rates for a site contract.

Informed consent must be understood

Good Clinical Practice requires that consent information is provided in language the participant actually understands, and ethics committees enforce it. A consent form that reads like a contract in the participant's second language fails that test even if every sentence is technically accurate.

How we translate consent materials

Medically qualified linguists translate at the reading level of the source, not above it
A second linguist reviews for comprehension: sentence length, terminology load, and whether an anxious layperson would understand what they are agreeing to
Assent forms for minors are adapted to age-appropriate language rather than mechanically translated

Evidence for your ethics submission

Committees and IRBs frequently ask for proof that a translation is faithful. Per document and language we provide:

A signed translation certificate identifying the translator and their qualifications
Independent back translation by a linguist who has not seen the source, where your SOPs or the committee require it
A reconciliation report explaining any differences the back translation surfaces

This is the documentation package reviewers expect to see, ready to file.

The UK picture

For UK sites, consent materials in community languages are routine for trusts serving diverse populations, and our NHS translation work means the register and format conventions your R&D office expects are already our defaults.

Linguistic validation of COAs and PROs

When a questionnaire measures an endpoint, translation stops being a language exercise and becomes a measurement exercise: the translated instrument must measure the same thing as the original, or the data cannot be pooled across countries. That is what linguistic validation is for, and it follows a recognised sequence rather than a single translator's best effort.

The process, step by step

Dual forward translation: two independent qualified linguists translate the instrument separately
Reconciliation: a third linguist merges the two versions, documenting every decision
Back translation: an independent linguist translates the reconciled version back to the source language, blind
Review: back translation compared against the original, with developer and clinician input where the instrument owner requires it
Cognitive debriefing: the translated instrument is tested with a small group of target-language respondents to confirm items are understood as intended
Final report: a full audit trail of versions and decisions, suitable for inclusion in a submission

This mirrors the good-practice principles published by ISPOR and expected by instrument developers and regulators. It is deliberately heavyweight, which is why honest scoping matters.

Endpoint instruments warrant validation; administrative documents need excellent standard translation. We will tell you which is which, because charging validation rates across a whole study file benefits nobody but the vendor.

eCOA and modality

Where instruments run on screens rather than paper, we handle character limits, string files and screenshots for review, working with your eCOA provider's formats through the same engineering pipeline as our software localisation practice.

The regulatory map: MHRA, EU CTR, FDA

Where your trial runs determines who reviews your translations and what they expect to see.

Swipe sideways to see both columns.

Where the trial runs	What language work the reviewers expect
United Kingdom	Combined MHRA and ethics review via IRAS; consent and study materials in the community languages of the population enrolled, with translation certificates in the submission pack
European Union	Single CTIS submission, but language did not centralise: Part II participant documents in each member state language, and lay summaries of results are an obligation under the Regulation
United States	FDA expects consent in a language the subject understands; certified translations are the practical standard
Rest of world	Set per national regulator, and varies widely; we maintain the per-country picture so your submission team does not reconstruct it per trial

This is where a translation partner covering 260+ languages with one project team earns its keep: one glossary, one memory, one accountable point of contact across every country in the study.

Consistency across a three-year study

The first translation of a study file is the easy part. The hard part is month 30: protocol amendment six, a consent form on version nine, and twelve languages that must all stay in step with each other and with the data already collected.

Version discipline

Versioned translation memory: each amendment is a delta against the approved previous version, so unchanged text stays verbatim and reviewers only re-review what changed
A locked study glossary from startup: drug names, endpoint terms and the phrases your medical monitor cares about
One linguist team for the study lifetime, with the glossary enforced on everyone who touches it

Speed when it matters

Routine documents run on standard 48 to 72 hour turnaround. Safety communications do not wait for routine: urgent safety measures, SUSAR-related letters and dear investigator communications go through our same-day service, in parallel across all study languages where needed.

Confidentiality and data protection

Study documents move over encrypted transfer, are stored in the UK, and are handled under NDA. Where source documents contain participant data, we work on pseudonymised text wherever the study design allows, and our processes are GDPR-compliant throughout. Blinding is respected: unblinded safety material is segregated to named linguists who see nothing else on the study.

How it works

Our process, end to end

Study Setup

Glossary of drug names, endpoints and study terms agreed at startup and locked for the study lifetime

Specialist Translation

Medically qualified linguist translates, matched to therapeutic area and document register

Second-Linguist Review

Independent review for accuracy, and for lay comprehension on participant-facing documents

Certificates & Back Translation

Signed certificates as standard, independent back translation and reconciliation where required

Versioned Delivery

Delivery against study version control, with memory updated so the next amendment starts from approved text

Who we serve

Built for these teams

CROs

Site startup document packs
Ethics submission translations
eCOA and paper instrument versions
Investigator communications
Study-lifetime consistency
Volume rates on programmes

Research Sites & NHS Trusts

Consent forms in community languages
Participant information sheets
Recruitment materials
Appointment communications
Interpreting for study visits
Fast single-document turnaround

Why teams pick us

What you get with Lingo Service

Medically Qualified Linguists

Translators with medical, nursing and life-science backgrounds, matched to the therapeutic area of the study

Ethics-Ready Evidence

Signed translation certificates, independent back translation and reconciliation reports for committee submissions

Version-Controlled Studies

Amendment deltas against approved memory: what changed is retranslated, what did not stays verbatim

Safety-Clock Turnaround

Same-day urgent lane for safety communications, parallel processing across every study language

Languages

260+ language pairs. These are our most-requested.

FAQ

Frequently asked questions

Yes. Every clinical document can be delivered with a signed translation certificate identifying the translator and their qualifications. Where your SOPs or the committee require it, we add independent back translation by a linguist who has not seen the source, plus a reconciliation report explaining any differences. This is the standard evidence package for ethics and IRB submissions.

Linguistic validation is the multi-step process used when a questionnaire measures a study endpoint: dual forward translation, reconciliation, back translation, clinician review and cognitive debriefing with target-language respondents, following recognised good practice. You need it for COAs and PROs that feed endpoint data. Administrative study documents do not need it, and we will tell you honestly which of your documents fall on which side of that line.

Same day. Urgent safety measures, SUSAR-related letters and dear investigator communications run through our urgent service, processed in parallel across all study languages so every site is informed at the same time.

Every study runs on versioned translation memory with a locked glossary. Each amendment is translated as a delta against the approved previous version: unchanged text stays verbatim, reviewers only re-review what changed, and the cost reflects only the changed text. The same linguist team stays on the study for its lifetime wherever possible.

Yes, this is routine work for us. We translate consent forms and participant information sheets into the community languages UK trusts serve, drawing on the same team as our NHS translation services, with certificates included for the R&D office.

Yes. Where instruments and diaries run on screens, we work in string files with character limits and provide screenshots for review, through the same engineering pipeline as our software localisation service. Paper and electronic versions of an instrument are kept aligned.

Documents move over encrypted transfer, are stored in the UK and handled under NDA. Where source documents contain participant data we work on pseudonymised text wherever the study design allows, and our processes are GDPR-compliant throughout. Blinded and unblinded material is segregated to separate named linguists.

From £0.10 per word depending on language pair and document type, with linguistic validation priced per instrument as a project. Repetition discounts of up to 50% apply automatically, which matters on protocols and consent forms where text recurs heavily. The online quote gives an instant fixed price, and study-length programmes get volume rates under our enterprise arrangements.

All the languages a global study realistically needs: we work across 260+ languages with one project team, one glossary and one memory, so a study running in fifteen countries has one accountable point of contact rather than fifteen vendors.

Ready to talk?

Upload your files for an instant quote, or talk to our UK team about your documents.