Clinical Trials, Linguistic Validation

Pharma Translations- Paspartu is expert at handling cross-cultural questionnaires for various PRO instruments, either in paper or electronic format, for pharmaceutical companies worldwide.

Linguistic validation measures the validity of the language employed in translation, assessing whether the patients in the target population fully understand the instructions, questions and response options detailed in the respective PRO instrument or measure. Linguistic validation helps us adjust our translation according to the patients' comments, which we report back to the client for final approval.

Our overall linguistic validation process follows the guiding principles outlined by ISPOR (the International Society for Pharmaeconomics and Outcomes Reasearch), as well as the QRD (Quality Review of Documents) Templates required by the European Medicines Agency for Marketing Authorisations Applications. 

Cultural differences may be substantive when they stem from semantic inconsistencies. Therefore, Paspartu applies several translation and evaluation methods for cross-cultural check. 

  • back translation, where the original translation is translated back into the source language by a blinded, independent translator. 
  • The two-source language versions resulting from forward and back translation are then compared and revised by a specialised translation team, and a harmonized version is issued. 
  • The harmonised or "reconciled" version is used by the project manager 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" and is usually followed by patient interviews or clinician review. 
  • 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.
  • After selecting the appropriate target patient groups, either a simplified linguistic validation test (pilot testing) for specific translated questionnaires is implemented, or an in-depth debriefing interview with the selected patients. Each patient is interviewed to confirm that his answers correspond to an understanding of the questions that is equivalent to that of similar patients in the source language.
  • 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. 


 What makes Greece and Central Europe in general 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 accesible healthcare infrastructures



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