Russia has always been a country of choice for global multicentre Phase III clinical trials: 70% of new drugs registered in Europe in 2015 were tested in Phase II-III clinical trials in Russia.
Russia is an attractive destination for early phase clinical trials. Rapidly developing clinical trials infrastructure, quick access to patient pool and availability of professional clinical trials suppliers adhering to good quality standards, attractive regulatory conditions, lower per-patient cost when compared with this in the US constitute key factors underlying the evolving trend. Also, a Pharma 2020 initiative aimed at successful creation and production of innovative medicines, which need to be tested in humans, and its export, gives impulse for this development.
The first private Phase I unit operating in accordance with international standards is BioEq. BioEq provides services from First-in-Human to Proof-of-Concept (in healthy volunteers, special populations and patients diagnosed with diseases in the field of oncology, rheumatoid arthritis and other therapeutic areas).
BioEq has carried out its mission of structuring the clinical trials market and provided a path for further development of infrastructure for clinical research. This has created a highly-standardized and qualitative environment appreciated by both local and foreign pharmaceutical producers.
BioEq has highly educated and experienced investigators. Its quality management system includes GCP training programs for investigational teams, and clinical research processes assuring that clinical research work is in accordance with international standards.
Russia has a number of well-established local service provider companies offering a full range of outsourced services, including clinical trial management (Phase I through Phase IV); clinical, medical, safety monitoring; preclinical, toxicology, clinical laboratory services for processing trial samples; data management, biostatistics, medical writing services; regulatory affairs support. Local and global companies realize that in today’s clinical trials standardization world, it is necessary to provide clients with high quality services and international ISO standards.
The first local company implementing ISO 9001:2008, a global standard for quality management, is Smooth Drug Development. The system ensures
adequate protection of subjects’ rights, safety, and welfare, qualified personnel, adequate clinical trial monitoring, current, complete, and accurate data. The company has also introduced a business continuity plan integrated with business operations and with all ongoing GCP activities.