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Regulatory challenge and patient safety
for translations for clinical trials


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.



 

Your requirements



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:

  • Seamless integration with the requirements
    of the CRO’s
  • Reliable, fast and cost-effective
    outsourced translation services
  • Centralised translation service rather
    than several different suppliers
  • Concurrent support across many different languages and in various regions
  • Short delivery times for additional
    new languages
  • Support for CROs for tenders that
    include language management and its
    correct positioning
  • Volume discounts and reduced prices for large-scale translation projects and
    tenders
 

Your advantages



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:

  • Customer-specific technical solutions
    and workflow design to combine clinical
    processes with language processes
  • Rapid processing times thanks to optimised workflows and defined practices in
    process control
  • Certified, prequalified and tested linguists using our resource management program and
    quality metrics
  • Expertise in the national language and
    familiarity with regulatory requirements
    for regional markets
  • Guaranteed quality using our unique quality
    assurance model, specifically developed
    for clinical trial translations
  • Specialised and flexible project management teams that grow with your requirements and your global reach

 

All phases of clinical trials


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:

  • Preclinical studies
  • Phases I–IV of clinical trials
  • Post-marketing surveillance studies
  • Non-interventional studies (NIS)


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.

 

 

All medical disciplines


Our range of services covers all medical disciplines such as

  • Gynaecology
  • Geriatrics
  • Cardiology
  • Dentistry
  • Neurology
  • Oncology
  • Orthopaedics and so on


thanks to the extensive experience our subject-matter experts have in these individual medical areas.

 

Different document types for
patients – investigators – authorities
require different processes


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.


  • Informed consent forms (ICFs)
  • Patient information sheets (PISs)
  • Case report forms (CRFs, eCRFs)
  • Patient diaries (e-diaries)
  • Patient cards
  • Patient-reported outcomes (PROs)
  • Investigator’s brochures
  • Protocol synopsis
  • Medical records
  • AE/SAE – Reports of adverse and serious adverse events
  • Study reports
  • Physicians letters
  • Site documentation and reports
  • Safety reports
  • Packaging and labelling of the investigational medicinal product
  • Patient information leaflets (PLs)
  • Summaries of product characteristics (SmPC)
  • Communication with ethics committees
  • Final report for clinical trials (clinical study report, CSR)
  • Contracts
  • Confidentiality agreements
  • Patient and clinician education material
  • Import/Export permits

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.

 

Special 24-/48-hour service for translations of adverse event (AE) and serious adverse event (SAE) reports


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.

Translation certificate


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.