13.04.2018

The ARS PharmRussia CRO won a tender for a Phase III double blind placebo-controlled parallel clinical study of efficacy and safety in patients with sleep disorder. 184 subjects will be enrolled at five investigative sites in Moscow, St. Petersburg, Yaroslavl, and Tver, Russia. ARS will be responsible for medical writing, project management, regulatory approval of the clinical trial at the Russian MoH and LECs, clinical monitoring, data management and statistics, final clinical study report preparation and submission to the regulatory authorities. The clinical research project will be performed in compliance with the Eurasian Union (EAEU) requirements. The final aim of the study will be marketing authorization of the product as an OTC drug.