Six of the top ten companies in the pharmaceutical industry rely on mpü’s expertise for clinical trial translations.
Clinical trials are increasingly conducted across national and language borders in very different countries. This internationality and therefore the diversity of languages spoken by subjects as well as any special features resulting from the geographical location are an enormous challenge faced by companies when carrying out and evaluating trials.
The specific requirements of each study require careful project analysis to ensure the most suitable customer-specific translation solution is applied. The various stages of a clinical trial each require different documents and are often subject to extremely tight deadlines and associated with enormous challenges.
As an expert with many years of experience across all phases of product development and marketing authorisation, mpü satisfies the requirements for multilingual clinical trials using proven translation and language management services based on a range of well-defined process stages. This is to ensure that all the documents and information we deliver are localised accurately, intelligibly for the specific target group and country in the native language – all in accordance with GCP guidelines.
Based on the type of clinical trials and the customer’s requests, the basic process can be expanded by additional subprocesses and value-added services.
Adaptable (scalable) and flexible translation and language management services play a key role for all globally active companies and CROs in multinational clinical trials and mpü offers:
Our flexibility and expertise enable all globally active companies and CROs to make the most of our capacities as a fully outsourced service or a partial service provider:
Translation of labels for investigational medicinal products taking into account Standard Terms
Label check for investigational medicinal products per country where there are study sites
When translating investigational medicinal product labels within the context of clinical trials, a so-called label check has to be performed for every language, and - depending on the country-specific regulations for each language or country - what this involves can vary.
With its goal of ‘100% quality’, mpü sets the most stringent standards for adapting processes to the individual documents and implements them at every phase of clinical trials:
Using our specialised translation and language solutions, we successfully support globally active companies and CROs while ensuring that a wide range of needs and working conditions are taken into account.
Our range of services covers all medical disciplines such as
thanks to the extensive experience our subject-matter experts have in these individual medical areas.
As an ISO 9001 certified provider, mpü offers translations of all documents for multinational use to all globally active companies and CROs.
Because the different types of documents are intended for different target groups – patients, investigators, authorities – the translations require different processes appropriate for the target group and the subject matter of the trial.
All translations and language processes are also linguistically and culturally adapted in accordance with the study timeline to satisfy legal and regulatory requirements. We supplement our range of services with multilingual DTP to match the specified layout.
So that the time-sensitive reporting of AEs/SAEs can be ensured (24/48 hours), mpü has set up a special service.
Our established and tested processes are oriented towards promptly preparing multilingual AE/SAE reports. The global position of our company and our experts means that we can make the most of different time zones so that this time-critical service can be offered.
mpü delivers a translation certificate for every translation option which contains details of the language and subject experts involved, a precise description of the selected process and the title of the document and language directions. Attestations, apostilles, etc. can also be provided for every document if required.