DOBYSS
Medical & Life Sciences

[샘플] Multilingual Clinical Trial Documentation for Global Pharma

Supporting a pharmaceutical company's global clinical trials with expert translations of regulatory documents across 8 languages.

MyLangsStudio Team|

Project Overview

This project required the expert translation of clinical trial documentation for a multinational Phase III clinical trial.

Scope

  • Languages: English to Japanese, Korean, German, French, Spanish, Italian, Portuguese, Mandarin Chinese
  • Document Types: Clinical protocols, ICFs, IB updates, regulatory submissions, patient diaries
  • Compliance: ICH-GCP guidelines, local regulatory requirements

Approach

Our medical translation team, comprising linguists with advanced degrees in pharmaceutical sciences, ensured every translated document met both linguistic quality standards and regulatory requirements specific to each target market.

Key Metrics

MetricResult
Regulatory Acceptance100%
Compliance Issues0
Avg. Turnaround5 business days
Translation Accuracy99.8%

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