People will still need drugs and the pharmaceutical industry won’t disappear. So the demand for companies conducting clinical trials will remain.
“EGeen International, Inc. is a global, specialized, rapid-response contract research organization (CRO) which provides a variety of key clinical services to advance the drug development of pharmaceutical and biotech companies,” explains Rauno Oja, managing director of EGeen.
EGeen offers a range of clinical trial services from rapid patient recruitment, clinical trial design, management and monitoring, to regulatory affairs and data management and analysis. “EGeen can help companies realize their clinical end goals in a rapid and cost-effective manner. We place particular emphasis on clinical trial rescue enrolment through rapid patient access and quicker, more personalized rapid response trial execution,” Oja points out.
According to Oja EGeen specializes in clinical trials of biologics, therapeutic vaccines, drug/device combinations and various formulations of small molecule drugs. “Our operational specialty areas are neurology, cardiology, oncology, psychology, urology and gastroenterology,” he adds.
“Essentially, EGeen’s task is to assemble the entire clinical study. CRO offers a complete service, meaning that we are able to carry out the study from the beginning to the end – write all the protocols and documents, carry out data management and monitor that the study is carried out in accordance with GCP (good clinical practice) requirements. After carrying out the study, we write a report and present a statistical analysis, and then we can submit the application directly to the FDA (US Food and Drug Administration) or EMA (European Medicines Agency),” says Oja.
“EGeen is headquartered in Silicon Valley, USA but the company is present in several European countries, for example, the Baltics, Poland, Ukraine, Romania and Georgia, Czech Republic, Hungary. Preparedness for conducting research exists in other countries as well, for example, the Scandinavian countries, Germany and Italy as well as other Western European countries. “This kind of circle has emerged purely because of need, for example, according to the study type and the number of patients,” he explains. The European operational head office is in Estonia – it provides an opportunity to combine presence, experience and price advantages with the international clinical standards required by the US or European Union.
Here comes the one important difference compared to competitors: “Presence in different areas allows us, first, a better understanding of clients and, second, more intensive communication on site as well as finding contacts. Presence builds confidence and easier communication helps to better understand the client and their needs,” he explains. Oja also emphasises a more distinctive approach from the competitors: “We have always tried to be as effective and quick as possible for the client and have dealt with several project rescues. We have developed certain labour standards over the years and we can cope with higher working stress.”
100% of export
EGeen’s main customers generally are pharmaceutical companies in the USA, Asia and Europe. In some cases other CROs need EGeen’s services. Competitors generally tend to be larger CROs that operate in several markets. “This means that selling our services to the Estonian market is quite hard if not impossible – there just aren‘t any drug manufacturers in Estonia. Few can be found but we are 100% export-oriented,” says Oja.
The number of ongoing projects is very different and may depend on the period: “A few years ago, there was significant oncological and neurological research going on, the second phase of which often lasts quite long. Now we are focused on biosimilars and generics, which means that the third stage of the studies may somewhat be shorter. The company may have up to a dozen ongoing projects, depending on their complexity, duration and the number of patients involved,” he explains.
According to Oja, for EGeen’s customers, speed and efficiency speak in favour of Estonia. “The Agency of Medicines and the committee for ethics work really fast and efficiently, always ready to consult, meet and give advice. Revision deadlines of applications are fast as well. The Estonian population is small and if the study wants to include more patients, the market here alone is not enough. But the processes are among the first to be initiated in Estonia. In some cases, the local digital systems or data will be of benefit because these facilitate the inclusion in the study or its conduct.”
Oja thinks that EGeen’s success is shown by the companies they have collaborated with and their recommendations. “We have joined certain projects later and worked with shorter deadlines and thus under greater pressure. We have managed. Therefore I believe that competence and quick action is our greatest value. This is how we have received several recommendations and many of our customers have returned. There probably aren’t many companies who can demonstrate that kind of number of successfully conducted projects,” says Oja.
Growth plans for the future
“People need medications and the drug market is unlikely to disappear somewhere in the nearest future. So the pharmaceutical industry is always in need of companies that conduct pharmaceutical research quickly and efficiently. In relation to the increased competitiveness of Eastern Europe and the increasing role of biosimilars and generics, the need for our service has grown even more,” Oja mentions.
EGeen’s future plan is to expand – the last year and a half has passed under the word “growth”: “We have created a strong team in Poland, Georgia, the Czech Republic and Hungary and increased our data management capabilities. We can offer our customers a full service and plan just to start realising our opportunities to the full extent,” he says.
EGeen sees their involvement in the Connected Health Cluster as an opportunity to simplify collaboration with other countries: “It’s good to keep an eye on start-ups or find solutions with already active businesses that would better cover the needs of our customers. The cluster also presents a good opportunity to put our heads together and, for example, organise joint ventures for the detection of new markets,” Oja finds.