Part of the European Union since 2007, Romania is a country located in Central-South Eastern part of Europe and has a population of almost 20 million and a total area of 238391 km2 that has all major landscapes.
Being one of the earliest European civilization, Romania is one of the 5 Latin countries in Europe alongside Italy, Spain, France and Portugal. Currently a real treat on the tourism pages due to the idyllic and quaint cites, fortified churches and painted monasteries, artful cites and well-known scientists, musicians, sculptors and sport-people, Romania is a nucleus of innovation and research.
Now with a centralized health system, Romania had the first hospital opened in 1704, Coltea Hospital and in here there was one of the first bases of medical education of the country- Nicolae Cretzulescu has set up here the microsurgical school.
With more than 40000 medical doctors, and 400 hospitals spread within the country, Romania offers multiple opportunities to perform clinical studies in many desired indications.
One of the most attractive aspects of the clinical research in Romania is the high number of eligible patients, the high enrollment rates and fast recruitment. Our Investigators offer decades of experience in clinical trials and based on their reliable assumption of enrollment rates we can manage each project in the most effective way.
The compliance of the patients with the protocol and the specialized and GCP trained site personnel together with our experienced monitors lead to a successful result and a quality of data with minimum queries for the statistic department, reducing therefore the timelines even more.
The legislation and regulations of the country are in line with the EU Directives and Guidelines and the principles of conducting the clinical trials are driven by the Declaration of Helsinki. Romanian Competent Authority and Ethics Committee are two official bodies involved in running the clinical trials. There are national inspections programs in place, the authorities having their own standards of operating procedures, based on the Inspections chapter from the European legislation. Even before the EU adhering, Romania had a Bioethical Committee, from 1992 that became the National Ethics Committee for clinical trials in 1998. The rapid evolution of the regulatory framework in Romania by the transposal of the EU regulations into National legislation is one of the main reasons the clinical trials domain is one of the main reasons the clinical trials increased rapidly from 75 in 2004 to 1800 in2015.