The need to translate and adapt patient questionnaires for use in multiple languages and geographical regions has grown rapidly. This is due, in part, to the global scope of many clinical trials, as well as to the new FDA and EMEA guidelines for using Patient Reported Outcome (PRO) endpoints from international clinical trials to support label claims.
ELC Group offers fully compliant Linguistic Validation services (including Cognitive Debriefing) to ensure item equivalence between an instrument’s original source text and translated versions. This can be critical to ensure that content validity is not affected by translation, and that data across sites can be pooled.
Our team includes specialists in the following areas:
- Psychiatry (including depression, schizophrenia, anxiety)
- Women’s Health