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OCT Clinical, one of the leading Eastern European CROs, has initiated a large-scale multinational study of a Central Nervous System drug in partnership with a U.S.-based biotech company.
This open label multinational multicenter study in 800+ subjects with relapsing multiple sclerosis is now launching across six countries of the Eastern European and CIS region.
“This is the second project we are running in partnership with OCT Clinical. The CRO’s expertise helped us make excellent progress with our study. Therefore, we had no hesitation reaching out to them again. Together with OCT, we are now working intensively on the study setup,” – Sponsor comments.
OCT Clinical will be responsible for running the study at 64 sites in 6 countries of Eastern Europe and the CIS region (Russia, Ukraine, Belarus, Serbia, Croatia and Georgia). The CRO has already obtained CTA approvals from the authorities in Russia, Ukraine, Belarus, Georgia and Serbia, and expects approvals from Croatian regulators in the nearest future.
“We are extremely happy and honored to be entrusted by the Sponsor to facilitate their CNS study and contribute to the development of their innovative drug. We hope that through the result of our partnership, patients worldwide will get access to an effective medicine. We are ready to apply our expertise and intimate knowledge of the Eastern European and CIS region in order to start the study and achieve outstanding trial results according to the sponsor’s plan”, says OCT’s Director of Clinical Operations, Irina Petrova.
OCT will be responsible for the full range of services within this study in all 6 countries – regulatory and logistics support, project management and clinical monitoring.