Clinical Trial Protocol – a Real Challenge for Translators

Clinical Trial Protocol – a Real Challenge for Translators

The protocol is a key document for every clinical trial. It is fundamental to the entire research project, defines the objective and describes the design of the study as well as details of the applied methodology and methods of statistical analysis. It provides...
Why is the process of translating regulatory submissions so unique?

Why is the process of translating regulatory submissions so unique?

Translation of regulatory submissions is often perceived as a necessary evil by clinical trial management teams, because it involves considerable financial outlays. Therefore, persons responsible for regulatory submissions are usually under a lot of pressure. Despite...