MediLingua Medical Translations

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

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!

Clinical Trial Document Language Translations

We offer language translations for clinical trial documents, such as the Study Protocol, Informed Consent Forms (ICF), Patient Reported Outcome (PRO) forms, Case Reports, Medical Ethics Committee (MEC) reports, et cetera.

In addition to our clinical trial document language translations, we can also provide translations for:

• Investigators' instructions
• Patient letters

Language Translations for Medical Device Documents

We also offer translations for medical device documents, such as Instructions For Use (IFU) and Operators Manuals, and information around surgical instruments, hospital equipment, and medical software.

Drug Registration Dossiers

We offer translations for Drug Registration Dossiers and for the registration of medicines, such as Summary of Products Characteristics (SmPC), packaging and patient information leaflets (PIL). We follow the QRD templates, as published by the European Medicines Agency (EMEA), and related guidance documents. We also offer readability testing for PILs, which has become a legal requirement.

Readability Testing: 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.

Our language translation services include translation by experienced medical translators, native speakers of the target language, medical editing, proofreading, page formatting and pre-press services, linguistic validation, in-country review coordination, readability testing, back translations, and cognitive debriefing.