ACCELL operates as a contract research organization (CRO) in Russia, Ukraine and Baltic States. We provide a comprehensive range of clinical trial services, including clinical trial monitoring in Russia and Eastern European countries.
Top reasons to place clinical trials in Russia and Eastern Europe
Suitable Demographics and Disease Profiles
With a total population of over 212 million potential study subjects, the region where ACCELL operates offers unsurpassed clinical trials market potential. The patients are of european origin with similar disease profiles. Russia is the largest European country with approximately 143 million population with treatment-naive patients in many indications, and as yet, an unrealised potential for clinical trials.
Low migration rates and patient compliance induced by the traditional respect of patients to their health care providers offer the benefit of high patient retention rates.
Large, mostly treatment-naïve population is accessible through centralized healthcare systems. Centralized medical centers serve the needs of the patients from large geographic areas, and patients with similar conditions are treated in the same department. Such structure opens up unparalleled access to a diverse patient population and allows companies to recruit up to 10 times faster than in the United States – reducing the time and money required to conduct a clinical trial.
Thus, the region yields an opportunity to reduce time to market and cost of research by drastically reducing the duration of the recruitment phase.
ACCELL has established networks of medical institutions in Russia and other countries, which allows rapid identification of the most effective patient recruitment solutions for any particular trial. The region's exceptional recruitment rates reduce the total time necessary to complete the trial and the investigator fees tend to be lower in this region than in the US and Western Europe. Combined, these factors lead to an overall highly competitive costs of clinical research.
High Quality of Data
High quality of data is derived from a combination of positive factors:
- ICH-GCP standards have been incorporated into the national legislatures.
- Requirements for Central and Local Ethics Committee Approval are applicable in all countries in the region.
- Medical education traditionally has been very powerful across the region, resulting in highly qualified doctors working in the national healthcare system.
- Strict national clinical trial regulations in Russia ensure participation of only the experienced investigators in the studies.
- Investigational Sites have prior experience in conducting industry-sponsored, ICH-GCP compliant clinical studies.
The quality of research is continuosly monitored by Sponsors, CROs, and FDA to ensure compliance to ICH-GCP and local regulations. Just in Russia alone, 28 FDA inspections have been conducted since 1996 until early 2006 with VAI or NAI classification, which confirms the quality of data.
ACCELL's Quality Assurance Department inspects all studies for compliance to ICH-GCP and local regulations.