Additional services

Interpretation

Linguistic validation

Formatting

Readibility testing

Interpretation

Document formatting is as equally important as the quality of the translation. The process of arranging translated text, pictures, tables and other graphics is a separate service provided by our DTP specialists who use professional software for layout and text design. This ensures that the document delivered to the client matches the layout and the format of the original document.

Formatting

Document formatting is as equally important as the quality of the translation. The process of arranging translated text, pictures, tables and other graphics is a separate service provided by our DTP specialists who use professional software for layout and text design. This ensures that the document delivered to the client matches the layout and the format of the original document.

Linguistic validation

Sometimes, an accurate translation of the original document is simply not enough. For example, if you are translating a Patient Reported Outcome (PRO) questionnaire for a multicenter trial, it has to be adapted to include terms that are appropriate for use in the target population and target region, understandable and unambiguous. If you want to investigate the impact of a disease on recreational activities, you would never use “playing golf” in Serbia, since this is not a typical sport for the region.

A linguistic validation process includes two forward translations by two independent translators, a reconciliation step in which the translations are compared and reconciled into one version that combines the best of both forward translations, a backtranslation into the original source language and a final review and creating a corrected translation. Usually this step is followed by a cognitive debriefing interview to ensure the content is valid and understandable.

Readability testing

In accordance with the EU Directive 2001/83/EC as amended by Directive 2004/27/EC all holders of marketing authorization for medicinal products are required to test Patient Information Leaflets for readability in order to ensure that a package leaflet is “legible, clear and easy to use”. The patients must be able to understand the text and easily find their way around the leaflet. This is why Quality Review of Documents (QRD) templates were developed; however, they do not exclude readability tests.

When registering a new drug in Serbia, according to the Rulebook on the Content of Application and Documentation for, and Manner of Obtaining a Marketing Authorization for Medicinal Products, the marketing authorization applicant may be requested to submit the readability tests upon request of the Medicines and Medical Devices Agency od Serbia. Even though Serbia is not a member of the European Union, the QRD templates applicable in Serbia are in compliance with the EU QRD templates.

Croatia is a member of the European Union, and the readability testing may be performed on any of the member states languages, while the results must be submitted to the Agency for Medicinal Products and Medical devices of Croatia in both English and Croatian. The applicant/marketing authorization holder is further required to ensure a high quality of the translation of texts into Croatian (read more at http://www.halmed.hr/Lijekovi/Upute-za-podnositelje-zahtjeva/Nadogradnja-dokumentacije-o-lijeku/Uputa-za-nositelje-odobrenja-o-ispitivanju-razumljivosti-i-jednostavnosti-Upute-o-lijeku).

Readability tests are performed for all other patient information (e.g. instructions for use) and patient questionnaires and PRO questionnaires.