Clinical Trial & Regulatory Translation

ICH-GCP compliant translation for clinical trials, regulatory submissions, and pharmaceutical documentation.

What We Translate for Clinical Trials

  • Informed consent forms (ICFs) — IRB/IEC-ready translations
  • Protocols & protocol amendments
  • Investigator brochures
  • Case report forms (CRFs)
  • Patient-facing materials — diaries, questionnaires, instructions
  • Regulatory submissions — FDA, EMA, PMDA filings
  • Safety reports & adverse event narratives
  • Labeling & packaging — IMP labels, package inserts
  • Site feasibility documents
  • Training materials — for investigators and site staff

Why Precision Matters in Clinical Translation

A mistranslated informed consent form doesn’t just create a compliance issue — it puts patients at risk. A mistranslated protocol can compromise an entire study.

They know the difference between “adverse event” and “adverse reaction” — and why it matters to the FDA.

Quality system: Translation → independent review → QA check → client review → finalization. Every step documented for audit readiness.

Compliance & Certifications

  • ICH-GCP compliant — Good Clinical Practice guidelines
  • 21 CFR Part 11 aware — electronic records and signatures
  • HIPAA compliant — protected health information handling
  • Translation memory — terminology consistency across studies
  • Back-translation available — for regulatory validation
  • Certified translations — certificate of accuracy for regulatory submissions
  • ATA Corporate Member — American Translators Association

Pricing for Clinical Trials

Clinical trial translation is project-based due to the specialized expertise and quality controls required. Pricing depends on volume, language pairs, and turnaround requirements.

Typical range: $0.12–$0.20/word for clinical documents with full QA workflow.

Volume discounts available for multi-study programs. Translation memory reduces costs on recurring document types (protocol amendments, updated ICFs).

Contact us for a project-specific quote: [email protected] or upload your documents.

Frequently Asked Questions

Yes. Back-translation is available for regulatory validation of informed consent forms, patient-facing materials, and other documents where independent verification is required.
Yes. We support 65+ languages and can coordinate multi-language rollouts with consistent terminology across all target languages using translation memory technology.
Every step is documented and audit-ready. We maintain translation memories for terminology consistency.

Get Your Clinical Trial Translation Services Today

A clinical trial file gets a quote review. Eligible standard documents are $19.99 per page. A birth, marriage, divorce, academic, or police record of up to 4 pages is delivered within 24 hours of order confirmation on business days, or that document is free. ATA corporate member #M-189351.

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