Medical device clinical trials conduct is one of the strategic directions of OCT development. We provide services on clinical trials and registration (marketing authorization) conduct within our regions (Russia, Belarus, Ukraine, the 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 was implemented in Russia in autumn 2009, the region becomes very promising in terms of placing medical device clinical studies there.
