Capitalizing on the local expertise in the global clinical research market as a success strategy

OCT Clinical Trials, a leading CRO on the Eastern European market, increases its share of overseas partnerships.

Pharmaceutical market is one of the few segments that have quickly evolved from national level to a truly global scale. Instant development of the more effective, affordable and innovative drugs requires a dynamic exchange of knowledge and competencies. Russian entities have been demonstrating active involvement in these processes. The field of clinical research is no exception, with Russia being a strategically important location and a full-fledged player on the global clinical trials market.

According to the Ministry of Health of Russia report, in 2018, 58% of all clinical trials in Russia were initiated by foreign companies, which amounted to 358 projects. Despite the general political context, following the results of the past year, sponsors from the USA take the lead in the total number of trials in Russia by having launched 108 projects in 2018, followed by companies from Switzerland with 73 projects. Today, Russian clinical research market, which started to take shape no more than 15 years ago, is an important strategic platform for large transnational corporations, medium-sized pharmaceutical companies and biotech firms with foreign and Russian capital, as well as young innovative developers.

"In 2005 there was no clinical research market in Russia as such. We were among the pioneers back then, and since there was practically no one around on the local market to ask for advice and follow the experience of, we immediately focused on leading global CROs as a benchmark, which, naturally led to a very high quality level of the services we provided,comments Dmitry Sharov, OCT Clinical Trials President.Ever since then, this has become a key priority in our strategy, which has resulted in exponential business growth, geographical expansion and extremely interesting cases, entrusted to us by our partners.”

By the end of 2018, the company’s portfolio included over 270 projects, with 31 started in 2018, a half of which were phase III studies. The number of international sponsors collaborating with OCT team increased by 13%. The company's financial performance also shows stable growth.

The company's traditional therapeutic focus on oncology, gastroenterology, neurology and infectious diseases has expanded. A record number of studies have been launched in ophthalmology: 5 projects in eye disease, including 1 study in glaucoma. The company’s practice pool now includes research on nutrition and immunology and allergology. In just one year, more than 4,500 patients were recruited into OCT studies.

According to the FDA (Food and Drug Administration), Russia ranks second by the number of patients participating in clinical trials, following the United States. Analysts are increasingly marking the choice of Central and Eastern Europe as a potential region for research.

The main factors determining the advantages of Russia are a well-developed scientific platform, an impressive number of leading clinical sites, high patient recruitment rate and favorable budget for conducting clinical research. The possibility of cooperation with experienced Russian CROs delivers a benefit of deep local expertise and a guarantee of world quality standards, which provides foreign sponsors with a considerable edge.

OCT has been delivering clinical research services in Russia, Central and Eastern Europe and CIS for more than 14 years. With the staff of 200 people the company operates in 7 countries, including representative offices opened in 2018. With a partner network of over 1,600 clinical sites around the world, OCT expertise includes a wide pool of KOLs and connections with the leading research institutions.

Another important aspect of a successful strategy in the era of digital domination is a solid technological platform. The digitalization and introduction of the latest developments to optimize workflows can further reduce the time spent on clinical trials, considering the amount of data CROs have to deal with and process on a daily basis.

In 2018, OCT initiated the transition to the BSI CTMS (clinical research management system). The customized version for the company is named STREAM. In addition to the wide functionality aimed at strict compliance of the project with deadlines, the system includes eTMF function, that allows sponsors to monitor a trial online with a 24/7 access from anywhere in the world, which essentially brings the quality of project’s workflow to a new level.

This year we expect a second wave of participation of state institutions in supporting clinical research, and not only in Russia,” Dmitry Sharov shares his view. “We are also pleased to observe one of the most important scientific breakthroughs in the industry in recent years — the emergence of cellular technologies. Finally, biomedicine in our country enters the stage when there is an opportunity to develop within the legal framework. There is a clear understanding of registration procedures and a solid regulatory platform.”

Being engaged in such a crucial stage of creating a drug as its research, OCT team is very well aware of the value new research ideas can bring to help save a life or significantly improve its quality. Within its corporate social responsibility policy, in 2018, OCT and Rakfond (Cancer Fund) initiated cooperation. Company transferred part of its revenue to the fund in order to support the most promising research projects chosen by the fund together with Russian and international experts on a competitive basis. In the future, the company plans to continue supporting programs aimed at identifying innovative and effective treatment methods.
This year, OCT plans to maintain this overall positive trend, increasing the growth rates by consistently expanding its geographical presence, developing new partnerships and following its motto - Local expertise. Global results. Back to the list