Pharma Translations for Clinical Trials and linguistic validation represent a specialized service offered by our Pharma Translations Unit. Translation of product documentation for the pharma sector is a very complex translation process. Specialized native pharma translators and Subject Matter Experts perform the translation which involves strict quality control checks.
Linguistics validation for clinical documentation
Linguistic validation measures language validity in translated Clinical Trials and PROs. It assesses whether the patients in the target population fully understand the instructions, questions and response options detailed in the respective PRO instrument or measure.
Translation and linguistic validation of PROs
Paspartu is expert at translating pharmaceutical documentation, namely cross-cultural questionnaires for various PRO (Patient Reported Outcomes) instruments, for pharmaceutical companies worldwide.
Pharma translations for clinical trials involve a series of adjustments that reflect the patients’ comments, which we report back to the client for final approval.
Our translation process follows the guiding principles outlined by ISPOR (the International Society for Pharmaeconomics and Outcomes Reasearch). Moreover, we implement the latest verions of QRD (Quality Review of Documents) Templates as the European Medicines Agency requires for Marketing Authorisation Applications.
Paspartu applies several translation and evaluation methods for cross-cultural check.
PROs instruments translation and linguistic validation- main steps
- forward translation, back translation, reconciliation of versions, back translation review
- Paspartu does not perform some other steps such as patient selection and interviews