Translation and linguistic validation

Translation and linguistic validation

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
  • Back translation is the step where the original translation is translated back into the source language by a blinded, independent translator. 

  • Next we compare the two-source language versions resulting from forward and back translation and we revise the resulting document with a specialised translation team. Finally, the team issues a harmonized version.

  • The project manager uses the harmonized or “reconciled” version to assess whether key concepts in the source questionnaire are accurately rendered in the target language.

  • This stage is known as the “back translation review”. Usually patient interviews or clinician review follow. 

  • This last stage of linguistic validation of a questionnaire represents the production of a translation which is conceptually equivalent, and culturally acceptable in the target country of use.

  • Pilot testing, in-depth patient debriefing interviews

    A company specialized in conducting clinical trials usually selects the appropriate target patient groups. Next. either a simplified linguistic validation test (pilot testing) for specific translated questionnaires is implemented, or an in-depth debriefing interview with the selected patients. The company interviews each patient to confirm that his/her answers correspond to an understanding of the questions that is equivalent to that of similar patients in the source language. However, Paspartu is not involved in selecting patient groups or in debriefing interviews with patients. We take care of the forward, back translation, reconciliation, and back translation review stages.

    Our detailed, specific project steps employed in linguistic validation measure the validity of the language employed in translated PROs.

  • Last but not least, the pilot testing phase consists of formulating probing questions on the patients’ perception of the translated measure, such as asking patients if they understood the questions, if they found any wording confusing, or whether they would express any questions differently etc. 

    Here you can see how to effectively translate Clinical Trials, SmPCs and PILs to initiate regulatory submission with the EMA

    Do you want to see real pharma translation projects successfully delivered by Paspartu? Check below:


 What makes Greece a desirable destination for clinical research and trials? 

  1. a large and easily accessible pool of patients
  2. highly qualified research personnel motivated to participate in trials
  3. cost-effective work force and project management for various clinical trials related services, such as multilingual translation and linguistic validation
  4. effective and easily accessible healthcare infrastructures
Medical Translation Solutions