Translations for clinical trials/clinical studies

Regulatory challenge and patient safety for translations of clinical trials

Six of the top ten companies in the pharmaceutical industry rely on mpü’s expertise for translations of clinical trials/clinical studies.

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 clinical studies.

We take on your challenges and support you through all of the stages of your medicinal product development and clinical trials.

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Quality assurance in the translation of documents from clinical trials

mpü quality assurance – skilled and precise

mpü has many years of experience of all stages of medicinal product development and marketing authorisation. With our experienced translation and language management team, we meet all of the requirements of multilingual clinical studies.

According to the regulations and recommendations of the

• EMA/FDA*/ICH-GCP guidelines and
• the authorities and ethics committees.

The priority of the internal mpü quality assurance is to ensure that all of the documents and information are created in a reliable and precise way for the respective target group and target country in the mother tongue of the study participants and localised in an understandable way.

Only perfect and localised translations ensure that patients both a willingness to participate on the part of the patients and their safety.

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mpü quality assurance – the steps to getting a high-quality product

mpü process –
linguistic validation and cognitive debriefing of PRO under one roof

Since clinical trials/clinical studies are increasingly being conducted at an international level, there is also a growing need for translation, harmonisation and cultural adaptation of patient-reported outcome measures (PROM) and for linguistic validation of the PROMs.

For PROMs, you can select a complete package for linguistic validation including cognitive debriefing or just select individual steps.

mpü – your expert for linguistic validation with cognitive debriefing of PROM

Translations + patient recruitment + testing under one roof

• Process BEFORE the start of the study to ensure that the study participants understand the content of the questionnaires properly
  
  
• Translations, where appropriate with back translations, of all questionnaires that will need to be completed by the study participants during the study
  
  
• Translations and cultural adaptation in all languages of the study countries
  
  
• Patient recruitment in all languages of the study countries
  
  
• Implementation of the tests (cognitive debriefing) in the study countries
  
  
• Patients interpret and evaluate the study questionnaires translated into their mother tongue to determine how easy they are to understand with no interference by the interviewer
  
  
• Depending on the result, the source text or the translation into individual languages may potentially need to be revised

mpü expertise

• mpü will support you with the development of strategies from the first steps of linguistic validation including the cognitive debriefing of PROMs.
  
  
• mpü will provide reliable PRO instruments which enable the successful implementation of your global studies.
  
  
• The mpü processes guarantee official acceptance.

Our network – your success

The global mpü network of

• Medical translators
• Subject experts
• Doctors
• In-country reviewers and interviewers
• Linguistic validators

means we have the option to carry out both the patient recruitment and the cognitive debriefing in the target country. Through this mpü procedure, we can ensure the scientific accuracy of the PROMs

The cognitive debriefing of the translated document is a step that is critical to the results. This process allows us to ensure that all patients understand the PROMs correctly and in the same way and are able to complete them in all target languages at a subsequent stage in the study.

From a linguistic perspective, each mpü project is equivalent in all languages. You can rely on your data from all countries being able to be pooled for the statistical analyses.

The quality standard for linguistic validation processes and the cognitive debriefing of PRO

The mpü expertise in the field of the translation and harmonisation of paper-based or electronic PRO instruments is based on our focus on translations of documents for globally active pharmaceutical companies and CROs.

The mpü processes and quality standard for the linguistic validation and the cognitive debriefing of PROMs follow all important guidelines: 

• PRO guideline of the American Food and Drug Administration (FDA) 
• Regulations of the European Medicines Agency (EMA)
• ICH-GCP standards
• Guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

All stages of marketing authorisation for medicinal products

With its goal of ‘100% quality’, mpü sets the most stringent standards for adapting all processes to the individual documents and implements them at every phase of medicinal product development:

• Preclinical
• Clinical phases I – IV
• Post-marketing surveillance studies
• Non-interventional studies (NIS)

Thanks to our specialised translation and language solutions that take into account a wide range of needs and working conditions, we successfully support globally active companies and CROs.

All medical specialties in 150 languages

You can take advantage of the full range of mpü services in all medical specialties as our linguistic and subject-matter experts have a great deal of experience in their subject areas.

These include, among others:

• Gynaecology
• Geriatrics

Different types of documents for
patients – investigators – authorities
require different processes

Because the different types of documents are intended for different target groups (patients, investigators, authorities, ethics committees), the translations require different processes appropriate for the target group and the subject matter of the document:

• Informed consent forms (ICFs) 
• Patient information (PISs)
• Case report forms (CRFs, eCRFs) 
• Patient diaries and e-diaries

Our multilingual DTP in accordance with the layout you specify supplements our range of services.

Special 24-/48-hour service for translations of
adverse event (AE), serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) reports

mpü has set up a special service to ensure that the time-sensitive reporting of AEs/SAEs/SUSARs can be complied with (24/48 hours).

Our established and tested processes are oriented towards promptly preparing multilingual AE/SAE/SUSAR 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.

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Country-specific label check for translations of labels for your investigational medicinal products

Translation and validation of labels for investigational medicinal products (study drugs) taking into account the standard terminology
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Label check for the investigational medicinal product labels for each country where study sites are located

Optimal use of resources for the highest quality

When translating labels for investigational medicinal products for clinical trials, the time and effort needed for the translation itself is relatively small. However, what is known as a label check has to be performed for every language, and its scope can vary depending on the country-specific regulations for each language or country.

Thanks to their comprehensive know-how for all language processes related to the marketing authorisation process and clinical trials, mpü has built a wide network of specialists for this specialised service. 

We have the ability to respond quickly to your specific requirements and we can develop these customised workflows with all of the steps for you. So your trial can start on time.

Label checks

The country-specific label check for the investigational medicinal product checks and adapts the translation of the master label according to the following criteria:

• Exact content of the master label
• Composition of the preparation 
• Investigated therapeutic indication
• Synopsis of the clinical trial (which determines the preparation type and usage conditions) 
• Language and country of the study sites to ensure the correct adaptation of the label content and thus compliance with the regulations in force in the respective country or region.

Thanks to our specialised translation and language solutions, we successfully support globally active companies and CROs to meet all their needs related to clinical trials.

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