From the Arctic Ocean to the Mediterranean Sea, in both Europe and Asia, with over 1,300 million prospective subjects, the area covered by GCT represents a popular destination for clinical trials.
If there were only three defining characteristics to choose for GCT, besides the geographic coverage already mentioned- that offers an interesting mix of EU and non-EU countries, these three benefits could be:
- Quality of collected data
- Experience > 15 years on the market
- High number of eligible and compliant patients
According to clinicaltrials.gov, the number of clinical trials in these areas is constantly growing, and we had in 2015 more than 3000 in Russia, more than 1800 in Romania, more than 1300 in each Ukraine and Bulgaria and close to 1000 in Serbia.
The opportunities to conduct clinical trials in GCT area are innumerable, and the constant request by the Sponsors for sites in these countries prove the opportunities are far greater than the risks that may come in each area due to the specificity of the domain.
Eastern Europe has a solid reputation for clinical trials, reputation built in time and based on strong quality systems, genuine interest of both Investigators and patients and last but not least the compliancy to rules and guidelines. Supported by strong and clear legislation systems, the record-setting approval timelines and the fast enrollment rates, the clinical trials performed in the area covered by GCT are ensuring their attractiveness with each project.
The quality of data obtained from these clinical trials is proved by the results of a multitude of audits and inspections performed in the sites. In the audits performed on GCT trials, more than 50 by now, most result with no major findings, and our QA team has taken upon themselves the motto of “No major findings”.
GCT experience on this market exceeds a decade, during which we had >5000 subjects enrolled in all countries, and that makes a population of a small town. Some of our clients have come to us for enrollment rescue and because we have a wealth of region-specific experience on how to facilitate the enrollment and the carefully selected sites that can reliably predict their enrollment rate, we can proudly state that these projects were successfully concluded. The large pool of treatment-naive patients in desirable therapeutic areas and the well trained site personnel lead to the high quality of data collected for the projects.
When it comes to Regulatory Affairs systems, we know we can count on our expertise, regardless of the country. The Authority Bodies in all the area require almost same documents, with annual reporting on the development of the project. For both EU and Non-EU countries the average realistic time for initial study approvals constitutes around 3 months.