TranslationsInLondon
Linguistic Validation & Independent Translation Review
Specialist language quality services for regulated environments — from full linguistic validation of COA instruments to independent translation review for clinical trials, pharmacovigilance, and regulatory submissions.
Request a scope assessment| Standard | ISPOR methodology |
| Regulators | EMA, FDA, MHRA |
| Turnaround | Scoped per project |
| Delivered from | London, UK |
Understanding the difference
These are related but distinct processes. Knowing which applies to your document type ensures you receive the right service — and the right documentation for your submission.
| Linguistic Validation (LV) | Independent Translation Review (ITR) |
|---|---|
For COA & PRO instruments. A structured, multi-step process — defined by ISPOR guidelines and required by EMA and FDA — that ensures a patient-reported outcome instrument is linguistically accurate, culturally equivalent, and conceptually consistent with the source. Involves multiple independent linguists and cognitive debriefing with target-population participants.
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For clinical & regulatory documents. A rigorous back-translation and bilingual review process performed by a specialist linguist with no prior involvement in the translation. Every ITR project includes a formal written review report and a signed Certificate of Translation Quality.
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New to the topic? Read our full guide: What is linguistic validation?
Designed for regulated environments
Our clients operate in highly regulated contexts where translation errors carry real consequence — regulatory, clinical, or legal.
| Pharma & biotech | Companies preparing multilingual regulatory submissions to the EMA or MHRA. |
| CROs | Managing multilingual clinical trials requiring validated patient-facing or site-facing materials. |
| Regulatory affairs teams | Requiring documented evidence of translation quality for submission packages. |
| MT-assisted workflows | Organisations using machine translation or post-edited MT who require independent human review and certification. |
| Medical device manufacturers | Requiring translation validation under EU MDR / IVDR. |
Document types we cover
| Document type | Service | Includes |
|---|---|---|
| COA & PRO instruments | LV | PRO instruments, eCOA/ePRO, ClinRO, ObsRO, HRQoL measures. Cognitive debriefing coordination available. |
| Safety & AE documentation | ITR | Adverse event narratives, ICSRs, PSURs, Risk Management Plans. |
| Trial & study materials | ITR | Informed consent forms, patient information sheets, CSRs, protocol amendments. |
| Regulatory submissions | ITR | CTD modules, SmPC, package leaflets, labelling and instructions for use. |
Our process
The steps below apply to both LV and ITR projects. For full LV, cognitive debriefing (Step 4) is included. For ITR, the process concludes at Step 5 with a Certificate of Translation Quality.
- Scope assessmentWe review the source document, target language, intended use, and applicable regulatory framework — and confirm whether LV or ITR is the appropriate service.
- Independent specialist assignmentA subject-matter specialist linguist is assigned with no prior involvement in the translation.
- Back-translation & bilingual reviewA blind back-translation is produced and reconciled against the source. For LV projects, forward translation and reconciliation precede this step per ISPOR methodology.
- Cognitive debriefingLV onlyInterviews are conducted with native-speaking participants from the target population, coordinated in partnership with our specialist LV consultants at GRC Health.
- Formal review reportA written report documenting findings, issues identified, resolutions applied, and confirmation of suitability for intended use.
- Signed certificateA Certificate of Validation (LV) or Certificate of Translation Quality (ITR) is issued — ready for your EMA, MHRA, or internal QA submission package.
Working with the best in the field
TIL's certified linguistic infrastructure operates within the broader LV process. For full LV studies, we work alongside specialist partners who lead methodology, cognitive debriefing design, and regulatory reporting.
Gibson Research Consultancy
CRO · Leeds, UK · Global reach
GRC Health is a Leeds-based contract research organisation led by CEO Mark Gibson, with decades of experience in clinical research and linguistic validation methodology. GRC brings the regulatory and scientific expertise that underpins every full LV study TIL supports.
Together, TIL and GRC Health offer a complete, end-to-end solution — specialist LV methodology led by experienced consultants, supported by TIL's certified, human-only linguist network across 220+ languages.
Why TranslationsInLondon
| ITI Corporate MembersSubject to the ITI Code of Professional Conduct. Verifiable via the ITI directory. | ISO 17100 alignedOur quality management processes follow ISO 17100 requirements. |
| Human only — no MTNo machine translation at any stage. Every validator is a qualified specialist. | Genuine independenceValidators are never the same person as the translator. |
| Formal documentationWritten review report and signed certificate issued for every project. | London-basedAvailable for client audits, regulatory team calls, and in-person meetings. |
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Request a scope assessment
LV is quoted per project following scope assessment. ITR is quoted per word or per hour depending on document type and volume.
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