Case studies

Case study “Efficient operations in Russia”

Final protocol was available on 22 Aug 2012.

Site selection was done within 3 weeks – 7 sites were visited and reports were submitted to the sponsor.

Regulatory submission was performed on 26 Oct 2012 and approval was issued on 27 Dec 2012.

The approval for the study was obtained one month before the set deadline, without questions or additional clarifications.

Core sites were initiated within 3 weeks, all sites within 6 weeks. Recruitment target was achieved one month before the scheduled LPFV date.