
Linguistic Validation
In clinical research, patient-reported outcome forms (PROs) are used to gather valuable insight into symptoms, side effects, and safety during clinical testing of pharmaceutical products.
Now more and more clinical studies are conducted around the globe and PROs come in from patients spanning multiple countries and many languages. To complete clinical research and fulfill regulatory requirements, companies need a translation partner who can provide linguistic validation for PROs correctly and quickly. Linguistic validation allows researchers to compare data accurately regardless of the original language in which the PRO was reported. In other words, it ensures 'apples to apples' responses across diverse linguistic groups.
Linguistic validation is a necessary step in moving a product from the lab to hospitals and pharmacies. Transline's linguistic validation process is carefully designed and follows these steps:
- Assessment of questionnaire content in source language
- Translation, editing and proofreading of questionnaire into target languages using native speakers
- In-country review of questionnaires
- Back-to-English translation to eliminate discrepancies