A mistranslated informed consent can halt your trial —
or invalidate your data.
You've invested years in this study. The last thing you need is an IRB rejection or FDA query because of a translation error. Taika Translations assigns ICH E6 GCP-trained specialists to every clinical document — so your protocol, ICF, and IND/NDA submissions clear review the first time. Back translation available on request.
Clinical trial translation at every phase — from IND filing to post-market studies.
Clinical trial translation errors aren't just quality issues — they can halt enrollment, delay IRB approval, and jeopardize regulatory submissions. Every document is handled by a translator with proven clinical research experience.
Patient-Facing Documents
Documents that must be written at the appropriate reading level, culturally adapted, and linguistically accurate for participant comprehension and enrollment.
Regulatory & Sponsor Documents
Submissions and technical documents for FDA, EMA, PMDA, and other regulatory authorities worldwide.
Pharmaceutical Documentation
Drug labeling, package inserts, and pharmacovigilance documents for global regulatory submissions.
Many IRBs and ethics committees require back translation of informed consent forms and patient-facing documents. Our back translation uses an independent second translator who has not seen the source document, followed by a reconciliation report — meeting ICH E6 GCP requirements and most institutional review standards.
Translation support from pre-IND through post-market surveillance.
Preclinical data summaries, pharmacology reports, CMC documentation, investigator brochure drafts, protocol synopses.
Full protocol & amendments, ICFs, investigator agreements, site initiation materials, eCRF instructions, SAE narratives.
Multi-country ICFs across 20+ languages, PRO/ePRO instruments, CSR modules, NDA/MAA submission packages, labeling.
PSUR/PBRER, pharmacovigilance case narratives, label updates, patient safety communications, post-market study documents.
A translation workflow built for clinical research.
Project scoping & NDA
We review your protocol, identify applicable regulatory standards (FDA, EMA, PMDA, ANVISA), and sign an NDA if required.
Translation + independent review
Primary translation by a clinical research specialist, then independent review by a second translator. Back translation by a third independent linguist.
Certified delivery
Delivered with a signed certificate of accuracy. Accepted by IRBs, ethics committees, and regulatory agencies worldwide.
Clinical trial translation FAQ
What is back translation and when is it required?
Back translation involves translating a document back to its original language using an independent translator who has not seen the source text. Required by many IRBs, ethics committees, and regulatory agencies (particularly FDA and EMA) for patient-facing documents like informed consent forms.
Do you translate informed consent forms for pediatric trials?
Yes. We translate both parent/guardian consent forms and child assent forms. Assent forms require age-appropriate language (typically 7–12 and 13–17 age cohorts), and our translators adapt reading level and tone to meet IRB requirements.
Can you handle multi-country trials requiring 20+ language versions?
Yes — multi-site, multi-country trials are a core competency. We manage simultaneous translation into 20+ languages with a single project manager and centralized termbase to ensure consistency across all versions.
How do you handle protocol amendments?
We maintain a translation memory for every trial document. When an amendment is issued, we translate only the modified content — reducing turnaround time and cost while ensuring consistency with the original approved translation.
What therapeutic areas do your translators specialize in?
Our translators have documented expertise across oncology, cardiology, neurology, immunology, infectious disease, rare disease, ophthalmology, endocrinology, and psychiatry. Credentials confirmed before work begins.
Keep your trial on schedule — get translations that clear IRB on the first submission.
Translation errors delay enrollment, trigger FDA queries, and cost months of work. With Taika, your ICFs, protocols, and regulatory submissions are handled by GCP-trained specialists — quote in 2 hours, rush delivery for hard deadlines.