Clinical Studies

Our pharmaceutical linguistic team specializes in clinical translation in more than 250 languages.

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At CSOFT, we’re frequently requested to work on a variety of clinical documentation.

Below are some examples of documentation we specialize in:

  • Phase 0 to IV
  • Pharmacology
  • Toxicology
  • Informed Consent Forms (ICFs)
  • Case Report Forms (CRFs)
  • AEs/ARs/SAEs/SARs/SUSARs
  • Adverse Drug Reaction (ADRs)
  • Package Inserts and Labels
  • Insert Leaflets
  • Development Safety Update Reports (DSURs)
  • IEC/IRB Correspondence
  • Clinical Services Agreements
  • Protocol & Protocol Synopses
  • Investigator’s Brochures (IBs)
  • Clinical Study Reports (CSRs)
  • Patient-facing Clinical Documents
  • Patient Information Sheet (PIS)
  • Patient Diaries
  • Summary of Product Characteristics (SmPC)
  • Instructions for Use (IFUs)
  • Scientific Papers

CSOFT Health Sciences Guarantees Quality Translation

devices
Scientific Accuracy
Cultural Adaptions
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Regulatory Compliance
biotech
Data Security and Confidentiality

Our Methodology

CSOFT guarantees medical translation methodologies that are compliant with regulatory and legal standards, as required by our pharmaceutical clients.

Our translators are native language subject matter experts with field knowledge translating specific content requirements. CSOFT assigns a team of senior medical translators, editors, and in-country reviewers to perform every translation project, with each individually responsible for translation, proofreading, editing, and independent review.

Our years of expertise and experience enables our team to customize operating processes on the basis of analysis on specific project requirements. Whenever necessary extra quality control steps of back translation, linguistic validation, and certification are performed.