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.
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:
- Concept elaboration
- Dual forward translation
- Harmonization
- Back-translation
- Survey Research Analyst review
- Developer review
- Clinician review
- Client subsidiary review
- Recruitment of patients
- Cognitive debriefing of patients
- Validation reports and certifications
Over our history, we’ve linguistically validated over 20,000 clinical outcome assessments in 500+ language pairs in over 200 different therapeutic areas. 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.
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