OCT, Clinical Trials 

OCT is an integrated drug development group with its core business in clinical and preclinical research, regulatory affairs, data management and marketing authorization with successful operations in Russia, Ukraine, Belarus, Bulgaria, Latvia, Lithuania, Estonia, Georgia, Germany and the USA since 2005.

Across these countries, OCT has a team of over 150 professionals, which is growing at a rapid pace. With more than 180 projects performed to date, we have solid experience in a wide range of therapeutic areas in Phases I-IV studies, as well as BE studies. The Company has a robust record of clinical research projects whose data were submitted to FDA and EMEA; some of the trials were conducted in the Russian Federation exclusively.

OCT provides the full-scale range of services to pharmaceutical, biotechnology and medical device companies:

∙    Study Feasibility

∙    Consulting

∙    Regulatory support

∙    Drug registration in Russia

∙    Investigator Meeting

∙    Medical Writing

∙    Project Management

∙    Clinical Monitoring

∙    GCP trainings

∙    Pharmacovigilance Services

∙    Quality Assurance 

∙    Data Management

∙    Statistics

∙    Clinical Supply Management

∙    Interactive Web Response System (IWRS)

∙    EDC