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.听
We modeled our linguistic validation process on the US FDA鈥檚 PRO guidance document and on ISPOR鈥檚 Good Practice recommendations. Our process includes the following key steps:听
- Concept elaboration听
- Dual forward translation听
- 贬补谤尘辞苍颈锄补迟颈辞苍听
- 叠补肠办-迟谤补苍蝉濒补迟颈辞苍听
- Survey Research Analyst review听
- Developer review听
- Clinician review听
- Client subsidiary review听
- Recruitment of patients听
- Cognitive debriefing of patients听
- Validation reports and certifications听
Over our history, we鈥檝e linguistically validated over 20,000 clinical outcome assessments in 500+ language pairs in over 200 different therapeutic areas.听
听
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.听
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