ICH E6 GCP-compliant translation for informed consent forms (ICFs), study protocols, investigator brochures, case report forms (CRFs), patient diaries, ePRO instruments, and clinical study reports (CSRs). Back-translation and reconciliation available. 50+ languages simultaneously for global multi-site trials. IRB-accepted. Regulatory-grade. Clinical research expertise.
ICH E6 GCP requires that informed consent forms be translated into a language the trial participant can understand, and that back-translation be performed to verify accuracy. Regulatory agencies — including FDA and EMA — may reject trial data if ICF translation procedures are not properly documented. Our GCP-compliant translation workflow produces the documentation your IRB and regulatory authority require.
Response within 2 business hours. GCP-qualified team assigned.
The most regulatory-sensitive trial document. ICF translation requires accuracy, appropriate reading level, and cultural adaptation. We translate ICFs with back-translation and reconciliation per ICH E6, FDA 21 CFR 50, and EU Clinical Trials Regulation. IRB-accepted in the US, EU, and globally.
Full protocol translation for submission to non-English-speaking regulatory authorities, Ethics Committees, and IRBs. Protocol amendments, synopses, and supplementary materials. Terminology consistency with all related trial documents maintained via translation memory.
Paper and electronic CRF (eCRF) translation and localization. Field labels, instructions, and validation messages. We work in all major eClinical platforms and export/import formats. Consistency with ICF and protocol terminology enforced.
Electronic patient-reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) instruments. Paper patient diaries, symptom logs, and quality-of-life questionnaires. Linguistic validation available to meet FDA PRO guidance and ISPOR standards.
Full and abbreviated CSRs per ICH E3 guidelines for submission to FDA, EMA, and other regulatory agencies. CSR translation requires deep statistical and clinical understanding — we assign translators with clinical research backgrounds, not general medical translators.
Site staff training manuals, investigator meeting materials, patient recruitment advertisements, screening questionnaires, and participant reminder letters. Culturally adapted for each target market — not just linguistically translated.
The source document is translated into the target language by a translator with clinical research domain expertise and native-level proficiency in the target language. Translator credentials are documented in the translation report.
A second, independent translator — who has not seen the original source document — translates the target-language document back into the source language. Discrepancies between the back-translation and original are identified and flagged.
A clinical language specialist reviews all discrepancies, resolves them with the original translation team, and finalizes the target-language document. A GCP translation report is issued documenting the full process, translator credentials, and resolution rationale — for your IRB and regulatory file.
Informed consent is the foundation of ethical clinical research. ICH E6 GCP, FDA 21 CFR 50, and the EU Clinical Trials Regulation all require that consent be sought in a language comprehensible to the subject. If an ICF translation is inaccurate, subjects may not truly understand what they are consenting to. FDA and EMA can and do reject trial data — including entire studies — if ICF translation procedures were not GCP-compliant.
Back-translation is the process of translating a previously translated document back into the original language by an independent translator who has not seen the original. It is the standard method for verifying translation accuracy in clinical research, recommended by ICH E6 GCP for informed consent forms and endorsed by FDA for PRO instruments. Many IRBs and regulatory authorities require documented back-translation for ICF submissions.
Yes. For global Phase II and III trials, we coordinate simultaneous translation into 50+ languages with a centralized terminology management system ensuring consistency across all languages and all documents. We operate in a project management framework with defined milestones, status reporting, and QC sign-offs for each language. Parallel delivery is standard — we do not deliver languages sequentially.
For each clinical trial translation project, we provide: a Translation Certificate (translator name, credentials, language pair, attestation of accuracy); a GCP Translation Process Report (for back-translation projects, documenting the full workflow, discrepancies found, and resolution rationale); translator CVs and credential documentation; and a glossary of trial-specific terminology. This documentation satisfies FDA, EMA, IRB, and Ethics Committee requirements for the investigator's regulatory file (ISF).
GCP-compliant ICF, protocol, CRF, and CSR translation with documented process for your regulatory file.