OCT Clinical to Run a CNS Study in Six European Countries
OCT Clinical, one of the leading Eastern European CROs, has initiated a large-scale multinational study of a CNS drug in partnership with a U.S.-based biotech company.
OCT Clinical, a leading Eastern European CRO, has initiated a large-scale multinational study of a CNS drug in partnership with a U.S.-based biotech company.
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.”
ST. PETERSBURG, RUSSIA, July 22, 2020 /EINPresswire.com/ -- OCT Clinical, a leading European CRO headquartered in Russia, today announced it will manage an open-label Central Nervous System (CNS) study. — Irina Petrova, Director of Clinical Operations, OCT Clinical
The multinational, multicenter study will follow over 800 subjects with relapsing multiple sclerosis (MS), a disease that causes damage to the CNS and results in a wide range of neurological symptoms. The study is now launching across six countries in Eastern European and the CIS region.
“This is the second project we are running in partnership with OCT Clinical,” said a representative from the Sponsor. “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.”
OCT Clinical will be responsible for running the study at 64 sites in Russia, Ukraine, Belarus, Serbia, Croatia and Georgia. The CRO has already obtained CTA approvals from authorities in Russia, Ukraine, Belarus, Georgia and Serbia, and expects that approvals from Croatian regulators will follow shortly.
“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,” said Irina Petrova, Director of Clinical Operations, OCT Clinical. “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.”
OCT will be responsible for the full range of services within this study in all six countries, including regulatory and logistics support, project management and clinical monitoring.
About OCT Clinical
OCT Clinical is the leading CRO in Russia, with operations in Central and Eastern Europe and the CIS region. With a team of over 200 professionals, the company provides a full range of high-quality clinical research services for phase I-IV and BE studies. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. OCT’s experienced team delivers both standalone services such as medical writing, consultancy, project management/monitoring, data management/biostatistics and turnkey service for clinical development. Since 2005, OCT Clinical Trials has worked on over 300 full-service and functional service projects in more than 20 therapeutic areas. Learn more at www.OCT-ClinicalTrials.com.
Amaliya Ilyasova
OCT Clinical
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