Steps in validating research instruments
Partnering with Corporate Translations ensures a thorough review and proper linguistic validation of the adapted instrument for use on an e COA or e PRO device when required.
Developing instrument translations for use on e COA devices requires early collaboration among the sponsor, e COA vendor and language service provider.
This important step can eliminate many technical problems and instrument administration issues later in the process.
We are a leading and trusted authority on the linguistic validation of Clinical Outcomes Assessments (COA).
Whether intended for a patient (PRO), clinician (Clin RO), or observer (Obs RO), our translations are accurate as well as culturally and conceptually equivalent to the source instrument.
Our state-of-the-art Linguistic Validation process is modeled on the U. Food and Drug Administration PRO guidance document as well as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations.
Our rigorous approach ensures that all clinical outcomes assessments translated for your trial are accurate and culturally equivalent to the source.
Our linguistic validation process is modeled on the U. Food and Drug Administration PRO guidance document as well as on the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations.