Linguistic Validation of COAs

Our state-of-the-art linguistic validation process and COA value-add services ensure both accuracy and timely completion of Clinical Outcomes Assessments.Ìý

We modeled our linguistic validation process on the US FDA’s PRO guidance document and on ISPOR’s Good Practice recommendations. Our process includes the following key steps:Ìý

  • Concept elaborationÌý
  • Dual forward translationÌý
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  • µþ²¹³¦°ì-³Ù°ù²¹²Ô²õ±ô²¹³Ù¾±´Ç²ÔÌý
  • Survey Research Analyst reviewÌý
  • Developer reviewÌý
  • Clinician reviewÌý
  • Client subsidiary reviewÌý
  • Recruitment of patientsÌý
  • Cognitive debriefing of patientsÌý
  • Validation reports and certificationsÌý
Over our history, we’ve linguistically validated over 20,000 clinical outcome assessments in 500+ language pairs in over 200 different therapeutic areas.Ìý
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Whether intended for a patient (PRO/PerfO), clinician (ClinRO), or observer (ObsRO), our translations are accurate and culturally and conceptually equivalent to the source instrument.Ìý

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