Clinical trials in Ukraine.
Ukraine is rapidly emerging as a global clinical trial provider. According to the Ministry of Health of Ukraine the number of regulatory clinical trial approvals have been increased from 38 in 2001 to 187 in 2007 with the yearly overall number of approved investigator sites from 175 in 2001 to 1308 in 2009. The local market of clinical trials is estimated by Polish market research company PMR at around EUR 208 000 000 in 2011 with the predicted growth rate of 10 – 20% over the next three years.
Ukraine has achieved 15% of its potential as per European Business Association data. Data proves to be true after comparison with neighboring Poland that has less population (38,000,000 against 45,000,000). Thus, Poland was engaged in active 2,512 studies while Ukraine had 320 ongoing trials in 2011.
The unique combination of the factors makes Ukraine almost ‘ideal’ location for clinical drug development. So Advantages of the Ukrainian Clinical Trial market:
- Good geographical location and demography
- Matured clinical infrastructure
- Well-developed public health care system
- Regulatory policy
- Study performance
Clinical Trial Logistics
The clinical trial logistics is a specific area that requires well-found providers to meet stringent sponsor and regulatory requirements. The logistical aspects are critical for clinical study success. That is why the selection of the logistical vendor is also the task of great importance and should be based on the criteria of quality, performance and expertise. The stakes grow even higher in the Eastern European and post-soviet countries where the regulations are not as well advanced and stable as in the developed markets and the experience of the vendor becomes absolutely crucial.
The clinical logistics is project-based by its nature. That requires involvement of Clinical Logistics Manager at the early project stage to forecast logistical needs and risks, calculate budget, set up timelines, select vendors and prepare Clinical Supply Plan. Experienced Logistics Manager is absolutely needed to manage the supply chain effectively and cost-efficiently.