lay summaries ofCLINICAL STUDY RESULTS

Ensuring transparency of clinical trials is a vital part of the process.

The European Union Clinical Trials Regulation 536/2014 (EU CTR) sets the requirement for sponsors of clinical trials to submit easy-language summaries of the results in local languages of all EU countries where the study was conducted. These summaries are meant to enable laypersons with limited scientific knowledge and low to average literacy skills to understand the study results.

At KONTEKST, we are aware of how challenging translating such documents can be. Keeping the original meaning while using a language understandable to the general public and ensuring cultural validity of the terminology used requires a very specific translation know-how. As an experienced life sciences translation provider, we offer comprehensive services designed to meet all the needs of Contract Research Organizations connected with these types of documents. In addition to an expert forward translation, we offer back-translation and reconciliation services to ensure sensitive translation projects such as lay summaries are translated accurately in terms of content and style.

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