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.

devices

PRO Questionnaires

ClinRO Questionnaires

cro

eCOAs/ePROs

biotech

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

Contact us for more information

xxx@csoftintl.com
+1 (888)888-8888

Other Medical Translation Services

CONTACT US

info@medl10n.com

+1-415-889-8989

US Headquarters

580 California Street, Suite 1330
San Francisco, CA 94104

Asia Headquarters

World Financial Centre, 15F
No.1 East Third Ring Road
Beijing, China 100020

Europe Headquarters

Neumannstraße 10
40235 Düsseldorf

 

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North America Headquarters

580 California Street, Suite 1330 San Francisco, CA 94104

Asia Headquarters

World Financial Centre, 15F No.1 East Third Ring Road BeijingChina 100020

European Headquarters

Neumannstraße 10 D-40235 Düsseldorf, Germany