Quality Control

DWL’s Quality Control procedures are a key element of its Quality Management System (QMS), which involves the following for:

 

All projects:

  • Selection at the outset of translators and reviewers best qualified to undertake the work. DWL’s Medical Director provides valuable support for Project Managers in this step. The presence of in-house expertise also enables medical queries to be resolved, thereby facilitating the translation process.
  • Checking, on completion of the translation process, by a reviewer (who also is a DWL approved linguist).
  • Visual checking to ensure that all the source text has been translated and that all figures and symbols have been included in the translation and, when applicable, that the document is QRD compliant and consistent.


The following extra services are available for:

 

Books and scientific papers for publishing:

  • Polishing/editing by one of our medical editors thus rendering the document fit for publishing.


MAA Product Information and other documentation:

  • Linguistic consistency review to ensure that the Product Information of a medicinal product, involving more than one strength and/or presentation, is linguistically consistent throughout. This is frequently required, in the EMA's Centralised Procedure, after linguistic review by the National Competent Authority, or after the Product Information has been subject to many Variations by different parties.


Clinical Research and other documentation:

  • Back-translation where a source text (e.g. protocol, patient information sheet, investigator's brochure) is translated into a forward (target) language and the forward (target) language text is translated back into the source language by an independent translator who has not had sight of the source text and will therefore provide an unbiased rendition of the meaning of the forward translation. Thus, back-translation allows a "non-speaker" of the forward language (i.e. the client) to check whether the forward translation gets across the essence of the source text.
  • Linguistic validation, such as Patient Cognitive Debriefing, can be used to validate translations by questioning a sample of subjects/patients, in the target country, as to their understanding of the translated document. This quality control method is used for Patient Reported Outcomes (PROs) and Quality of Life (QoL) instruments ensuring compliance and accuracy of data in international clinical trials.


Certificates of Translation are available on request.