Hub Projects

Romania holds significant potential for hosting clinical trials, meeting many of the necessary conditions to attract them, as noted in the 2020 IQVIA study “Development of the clinical trials market in Romania.”

Compared to smaller countries like Bulgaria and Hungary, Romania lags behind in the number of clinical trials conducted. Prior to recent legislative reforms, Romania was classified as “significantly underdeveloped” in this area.

The country benefits from a large and efficiently recruitable patient pool and maintains data quality on par with neighboring countries, in line with EU standards.

Costs remain competitive, and investigators are well-trained, educated professionals as of 2019.

The regulatory framework for clinical trials has seen significant improvements, creating a favorable environment for Romania’s potential.

There is an opportunity for clinical trials to become a strategic pillar of Romania’s economic competitiveness and access to treatments, with substantial socio-economic impact.

The local regulatory framework is fully compliant with European Union (EU) regulations.

Romania has the opportunity to increase the number of studies conducted at the regional level if it chooses to invest in this pillar of research and innovation.

The legislative framework for approving clinical trials in Romania has been significantly improved, thereby creating the right context to maximize the country’s potential to attract and conduct clinical studies.

There is an alignment of key stakeholders that can quickly turn the topic of clinical trials into a strategic pillar of Romania’s economic competitiveness and access model, with significant socio-economic impact.