Linguistic Validation


For 20 years, ICON Language Services has been dedicated to providing high-quality translation and linguistic validation services to the clinical research industry. Our services have been certified to the ISO 17100:2015 quality standard, the international standard that unifies the terminology used in the translation industry, which defines basic requirements for language services and creates a framework for the interaction between customers and service providers.

ICON Language Services has worked on several hundred COA instruments, including gold-standard measures such as the EQ-5D, the SF-36, and EORTC oncology modules. We have translated and validated instruments for use in Europe, Asia, North and South America, Australasia and Africa.

Linguistic validation of Clinical Outcomes Assessments (COAs):

  • Patient Reported Outcomes (PROs) including ePRO
  • Clinician Reported Outcomes (ClinROs)
  • Functional assessments
  • Cognitive tests
  • Review of eCOA screenshots
  • Cognitive debriefing interviews
  • IVRS prompt recording and system testing

ICON is a prominent and active contributor to scientific and regulatory debates about the development, translation and validation of COA measures. Most notably we have contributed to the creation of international standards and guidelines.

Our work complies with international regulatory requirements, in particular the FDA guidelines on translation and validation of PRO measures. Our team provides certification and reports detailing the methodology used, which can be incorporated into submissions to ethics committees and regulatory authorities.