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Clinical trials follow a set of rules, known as a research protocol, which defines things such as the main goal of the study, the criteria for inclusion or exclusion of patients and ensures that they measure the right points in the right way and that the results are meaningful.
In this process, clinical documentation serves multiple purposes and needs to be friendly for different audiences, from technical experts to laymen. It is thus essential that the results of the study be equivalent across multiple languages. The slightest mistake could even endanger the lives of the people under research.
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MDR is the new set of regulations governing the production and distribution of medical products in Europe. In this article, we tell you all about this new regulation.
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