TRANSLATION OF CLINICAL PROTOCOLS

A detailed clinical protocol is usually developed by the sponsor for each clinical trial. The clinical protocol describes the purpose of the research, explains how the trial will be conducted and how the results are analyzed.

An ethics committee must review the protocol before the trial can begin. Protocols are prepared in accordance with the internationally accepted good clinical practices guidelines developed by the International Conference on Harmonisation (ICH). Some countries require that a translation of the clinical protocol be filed in order to conduct the clinical trial. Sometimes, it is sufficient to file a protocol synopsis.

Global Translation translates clinical protocols and protocol synopses for leading pharmaceutical companies and CROs in the following languages: English, Spanish, German, French, Italian, Danish, Swedish and Hebrew.