MediLingua Medical Translations - Clinical Trial Documents, Surgical Equipment, Product Labels and Protocol Language Translation

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MediLingua is specialised in translating medical labels and pharmaceutical product labels into all European languages and Japanese. We translate documents and information concerning medical devices, medical equipment, surgical instruments, in-vitro diagnostics and active implantable devices. We translate documentation for clinical trials, such as protocols, informed consent forms (ICF), patient reported outcome forms (PRO) documentation, and drug registration dossiers.

With teams of experienced medical translators in all European countries and Japan, we offer the best of two worlds: a one-stop project management and quality control service, and translations done in-country, by native speakers of the target language.

Because we like what we do, it is easy for us to do a good job!

Language Translations for Clinical Trial Documents

We offer Language translations for clinical trial documents, such as:

  • Protocols
  • Informed consent forms (ICF)
  • Patient reported outcome forms (PRO)
  • Investigators' instructions
  • Patient letters
  • Medical ethical committee (MEC) reports

Language Translations for Medical/Surgical Equipment

We offer language translations for medical equipment documents and surgical equipment documents, including:

  • Instructions for use (IFU)
  • Operators manuals
  • Medical software user interface

Language Translations for Drug Registration Dossiers

We offer language translations for Drug Registration Dossiers and the registration of medicines, including:

  • Summary of Product Characteristics (SPC)
  • Patient Information leaflet (PIL)

We follow the QRD templates, as published by the European Medicines Agency (EMEA).

Readability Testing of Patient Information Leaflets

We also perform readability testing (usability testing, user testing) of patient information leaflets (PILs), which has been a legal requirement since 2005. Two test panels of each 10 participants will answer a range of questions about the contents of the PIL. They will have to be able to find and understand the related information in the PIL.

We will ensure that the PIL follows the current QRD templates, the EC Readability Guideline, and all other related guidance for readability testing. The report will describe the test methods, the profile of the test participants, the key safety issues, the questions, and the results of the different test rounds.

Medical Translation Services Include:

  • Translation
  • Editing
  • Proofreading
  • Page formatting and pre-press services
  • Validation management
  • In-country review
  • Readability testing
  • Back-translations

Contact:

MediLingua Medical Translations BV
Poortgebouw, Rijnsburgerweg 10
2333 AA Leiden
The Netherlands

Tel: +31 71 5680862
Fax: +31 71 5234660

Articles by MediLingua Medical Translations

Document Translation

  • Clinical Trials and Translation »
    This article discusses some language and translation aspects of international clinical trials, and how a poorly translated 2-page document can delay the registration procedure.

Efficient Medical Translations

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