Medical device clinical trials conduct is a new strategic direction of OCT development. We would be glad to provide you with the services on clinical trials and registration (marketing authorization) conduct within our regions (Russia, Belarus, Ukraine, Baltic States, Bulgaria):
- Consulting and Medical writing
- Feasibility analysis and report
- Project management
- Regulatory consulting and submission
- Clinical monitoring
- Logistics support and clinical trial product distribution
- Purchase of concomitant medication
- Reimbursement
- Audits
Among OCT countries Russia is the biggest region to place clinical investigations and the largest market to enter. Since ISO14155:2003 is to be implemented in Russia in autumn 2009, the region becomes very promising in terms of placing medical device clinical studies there.
Due to the present requirements, i.e. Administrative regulations of Federal Service on Surveillance in Healthcare and Social Development in the Russian Federation on Execution of State Function for Marketing Authorization of Medical Devices (Order as of 30-Oct-2006 #735 of Ministry of Healthcare and Social Development of the Russian Federation), medical device clinical trials in Russia could be performed within registration process. Nevertheless, the trials could be conducted in accordance with ICH-GCP, EU MDD, and FDA regulations. Furthermore, nowadays numerous post marketing studies take place in the country and the number of them is increasing day by day.
