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 performed by specialized native pharma translators and Subject Matter Experts, and involves strict quality control checks.

Linguistic validation measures language validity in translated Clinical Trials and PROs, assessing whether the patients in the target population fully understand the instructions, questions and response options detailed in the respective PRO instrument or measure.

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 involves a series of adjustments that reflect the patients’ comments, which we report back to the client for final approval.

Our linguistic validation and clinical trials translation 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 Authorisation Applications.

Paspartu applies several translation and evaluation methods for cross-cultural check.

The main steps of the translation and linguistic validation of PRO instruments are: forward translation, back translation, reconciliation of versions, back translation review. Some other steps such as patient selection and interviews, are not performed by Paspartu.

  • 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 harmonized 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.

  • A company specialized in conducting clinical trials usually selects the appropriate target patient groups, and 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. Paspartu is not involved in selecting patient groups or in debriefing interviews with patients- we only take care of the forward, back translation, reconciliation, and back translation review stages.

    Our detailed, specific project steps employed in linguistic validation are meant to 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 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 accessible healthcare infrastructures
Medical Translation Solutions