Clinical Trial Translation Services

• 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

• 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.

• 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

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.

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.

1. Dual forward translation: two independent qualified linguists translate the instrument separately
2. Reconciliation: a third linguist merges the two versions, documenting every decision
3. Back translation: an independent linguist translates the reconciled version back to the source language, blind
4. Review: back translation compared against the original, with developer and clinician input where the instrument owner requires it
5. Cognitive debriefing: the translated instrument is tested with a small group of target-language respondents to confirm items are understood as intended
6. 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.

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.

• 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

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.

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.