Translation and Linguistic Validation of PRO measures
Translation and Linguistic Validation is a fundamental part of the PRO instrument development process. This process, when properly undertaken ensures that PRO data pooled from international trials has scientific validity, and hence credibility with regulators and the healthcare market. Regulators, including the FDA and EMA, increasingly require that fully compliant Translation and Linguistic Validation processes underlie evidence used to support regulatory submissions and labeling claims.
For over a decade Oxford Outcomes has been a market leader in the Translation and Linguistic Validation of PRO measures. We have worked on several hundred PRO measures, including gold-standard scales such as the EQ-5D, the SF-36, and EORTC oncology modules. Our team has translated into over 80 European, Asian and African languages, in compliance with FDA guidelines, and working to the very highest standards.
We have arguably the strongest group of investigators and translators in our sector, since 1994, this investigator and translator group has been built from our extensive academic, scientific and commercial networks. Our quality control systems ensure that our investigators and translators are properly developed and managed, and return work of the highest standard.