Linguistic Validation of your COA

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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