Before running a clinical study, it is important to consider multiple factors before choosing the country in where it will be performed. Lets take a look at why Romania and Bulgaria are great options to conduct a clinical trial.
Population.
With a population of 20.1 million (Romania) and 7.28 million (Bulgaria), together they represent 5.3% of the total EU citizens. Romania has been ranked the 7th largest country within the EU in terms of population, so the pool of potential patients is one of the largest in Europe.
Regulatory Environment
Both Romania and Bulgaria have adopted and fully implemented the EU Clinical Trials Directives. According to this regulation, it takes 2 months to obtain regulatory approval in these countries, which is less that we can expect from other European countries. This is one of the main reasons behind the decision to conduct a Clinical Study in this geographical area.
Quality:
There are 17 medical universities in Romania and 5 medical schools in Bulgaria, while the number of university clinics stands at 39 units in Romania and 15 in Bulgaria. They provide similar infrastructure and diagnostic capabilities than Western standards and more practitioners are employed by teaching hospitals and university clinics than in Western Europe. It all results in an excellent overall quality of work.
High recruitment rate:
Their outstanding recruitment performance is linked to:
– A large and heterogeneous patient population
– Preventive medicine and therapy are not always available, so there is an important percentage of eager patients
– Full range of multi-specialty medical institutions with highly educated medical teams who are very motivated to take part in clinical trials from Western companies because it is a sign of academic distinction.
Cost-effectiveness:
With one of the most competitive ratios of cost-effectiveness in Europe, costs (for both monitoring and investigating) are dramatically lower than those in Western Europe. Statistics speaks for themselves: monitoring costs are around 50 -70% higher in Western Europe. Furthermore, additional costs such as accommodation or flights are also lower.
In conclusion, Romania and Bulgaria are a great and affordable environment in which to perform clinical studies in Europe. If you are still considering different countires for your clinical trial, take a look at Spain and Central Europe.