Simultaneous interpreting of medical conferences and congresses
Consecutive interpreting: assistance for patients and/or medical professionals and pharmaceutical companies requesting clinical study audits
Whether consecutive interpreting or simultaneous interpreting is required, the interpreter must have extensive medical knowledge. The interpreter must also understand the differences between interpreting for audiences comprising the general public and audiences comprising science professionals. Scientific audiences easily understand professional terminology, even if it is in a language other than their mother tongue, but patients and the general public require more skill and experience on the part of the interpreter.
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.
In certain situations, an exact translation of the original document is not sufficient. For example, if you are translating a Patient Reported Outcome (PRO) questionnaire for a multicenter study, the questionnaire must be adapted to include terms that are appropriate for use with the target population and in the target region, terms that are clear and unambiguous. For instance, when assessing the impact of a specific disease on recreational activities, you would never ask about “playing golf” in Serbia, as that sport is not typical for the region.
The cultural adaptation process (also known as linguistic validation) involves two independent forward translations from the source to the target language performed by two separate translators, followed by a reconciliation step, where the translations are compared and harmonized into a single version that combines the best elements of both. This is followed by a back-translation into the original source language and a final review and refinement of the translated content. After this step, a cognitive debriefing interview is typically conducted to confirm that the content is appropriate and clearly understood.
In accordance with EU Directive 2001/83/EC, as amended by Directive 2004/27/EC, all marketing authorization holders are required to test the readability of the package leaflet to ensure that it is “legible, clear, and easy to use.” Patients must be able to understand the text and easily navigate the leaflet. This is the reason why Quality Review of Documents (QRD) templates were developed, to help ensure document quality — but these do not replace the requirement to conduct readability testing.
When registering a new medicine in Serbia, according to the Rulebook on the Content of the Application and Documentation, and the Procedure for Obtaining Marketing Authorization, the Medicines and Medical Devices Agency of Serbia may request a readability test from the applicant. Although Serbia is not a member of the European Union, the QRD templates used in Serbia are aligned with those of the European Union.
Croatia, as an EU member state, allows readability testing to be conducted in any of the official languages of the EU member states, but the results must be submitted to the Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED) in both English and Croatian. Applicants/marketing authorization holders are also required to provide a high-quality Croatian translation of the leaflet. (More information available here)
Readability testing is also required for all other patient-facing materials, such as instructions for use, patient questionnaires, and Patient-Reported Outcome (PRO) instruments.