The niche contract research organization (CRO) August Research is headquartered in Sofia, Bulgaria, with operations in Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, and Slovakia.
The company this month has added operations in the country of Georgia and Moldova via an acquisition from the Pittsboro, NC-based CRO SPRI Clinical Trials. Financial terms were not disclosed.
Dana Leff Niedzielska, CEO of August Research, said the opportunity arose as SPRI was “winding down” operations in these countries. The acquisition was “a great way to get started there with an existing operation, ongoing projects, and staff,” she told us.
August Research will be keeping all local employees on staff and will integrate operations into its existing structure. The company’s senior managers based in Sofia will oversee the new locations “in the same way that we manage all our individual country operations,” explained Niedzielska.
Operating outside the EU
According to Niedzielska, Central and Eastern European countries are becoming increasingly popular destinations for conducting global clinical trials, due to faster enrollment times and lower costs as compared to Western Europe or the US.
“As the more developed countries become saturated with trials and more expensive, sponsors consider additional markets where there are fewer competitive trials and lower costs,” she told us.
“In the case of Georgia, the government has created a very fast clinical trial approval process to further encourage the conduct of clinical trials in the country,” Niedzielska added, “Currently, the timelines for regulatory approval in Georgia are significantly shorter than in the European Union.”
Niedzielska also noted that both Georgia and Moldova are outside of the European Union (EU), and as such are not required to follow EU Clinical Trial Regulations. She said, “For study sponsors who do not have the required trial documentation to run trials in the EU, working on the European Continent outside of the EU can be a great option.”
The company does not currently have plans to expand into additional countries in Central and Eastern Europe. However, Niedzielska said the company hopes to grow its existing operations through additional trial volume in the coming 1-2 years.
“While our infrastructure and focus is on Central and Eastern Europe (because we believe it is the most efficient region for conducting clinical trials) we also have a team of freelance CRAs in Western Europe, so we can provide services for our clients across Europe,” she added.
“By combining the locally based CRAs with our in-house regulatory and administrative support staff, we are able to offer our clients European-wide coverage for their clinical trials.”