Linguistic Validation for Clinical Outcome Assessments (COA)

To ensure the conceptual and cultural equivalence of your instruments in all languages

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Our linguistic validation team experience in the following areas and many others:

  • Oncology
  • Hematology
  • Cardiovascular
  • Respiratory
  • Central Nervous System (CNS)
  • Gastroenterology
  • Inflammation
  • Immunology
  • Infectious diseases
  • Metabolic diseases
  • Rare diseases
  • Vaccines

Over the past 16 years, CSOFT has built our global network of medical professionals and research associations which provides our team with in-depth expertise. This expertise is then leveraged for each COA project we deliver to our clients.

PRO Questionnaires
ClinRO Questionnaires
Patient Diaries

Our Methodology

CSOFT’s linguistic validation process is in compliance with both the U.S. Food and Drug Administration PRO guidance documentation, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations.

Key Steps of LV Project Cycle:
  • Face Validity Assessment
  • Dual Forward Translation
  • Back Translation
  • Harmonization Process
  • Patient Recruitment
  • Cognitive Debriefing
  • Back Translation
  • Validation Reports