The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason SMO Group has expanded its presence in Russia providing core services such as customs clearance, depot and distribution and comparator sourcing. Our Managing Director, Anastasia Shtro, shares some thoughts on country insights, recent legislation changes and SMO Group experience in providing services in CIS.
When and why has SMO Group decided to expand their operations in this region?
First of all I would like to mention that we have more than 15 years of experience in the field of clinical trials logistics in Central and Eastern Europe, with headquarter in the UK. As a part of its vision to become a global clinical trials logistics provider, SMO Group expanded its services to Israel, Georgia and Russia.
Expansion to Russia was a client-driven decision. There are plenty of multinational clinical trials that are conducted in various countries of CIS because of the access to a broad patient population and high recruitment dynamics. While having all countries of CIS under one roof, we can serve our customers efficiently by uniting local knowledge with the global expertise.
Which countries can you cover with the use of your brand-new Russian Depot?
The Commonwealth of Independent States (CIS) region is a confederation of 9 member-states and 2 associate members. CIS was formed during the breakdown of the Soviet Union and included most of former Soviet Republics. The members of CIS are Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan and Uzbekistan.
With new legislation coming into force SMO Group have an ability to cover the Eurasian Economic Union which includes the Russian Federation, the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan and the Kyrgyz Republic through our Moscow Depot.
Which new opportunities will arise together with the changes of regulatory system?
Firstly, the main driver of changes is the common Pharmaceutical market that already has no customs boarders, but still requires harmonization of legislation. The main changes are the following:
- all countries will operate under harmonized GxP standards
- there will be one Marketing Authorization Holder in EAE
- the packaging of the products will be unified
- the results of the clinical trials conducted in one country of EAEU will be recognized by other EAEU members
- there will be one authority issuing RA approvals and regulating import/export permissions
All of these create both opportunities in terms of patient outreach and disadvantages related to un uncertain legal environment.
You have mentioned that SMO Group has faced a growing demand for logistics support in Russia. What could be the main reason for pharmaceutical companies to be interested in this market?
There are several aspects to it.
The first part is a market attractiveness in general: cost-efficiency for trial conducts, short enrollment periods, qualified sites and Investigators, growing clinical trial infrastructure including early-phase trial sites.
The second part is devoted to a cold-chain management: the limited number of vendors that can provide the qualified services in multiple locations where the trials are conducted, climate and geographical parameters requiring special treatment and capacity issues on the market.
How do you diversify SMO Group on the Russian market?
SMO Group is positioned as a high-quality dedicated clinical trial logistic provider encompassing multiple locations (EAEU, Ukraine, Georgia, Israel) under one roof. We strive to provide our customers with added value services: Advanced therapy medicinal product (ATMP) logistics, direct-to-patient supply, patient-centricity services – through one stop shop customer support function.
Another key point is a large capacity. We have largest capacity on the market for frozen and ultra-low storage regimes as well as significant amount of space for ambient and refrigerated storage.
Could you briefly describe SMO Group experience in terms of local depot and distribution services in Russia?
Despite the fact that SMO Group is present in Russia for not so long, we have already been managing more than 60 ongoing protocols in various temperature regimes including: -15 -25C and -60 -80C storage. Our professional team has also managed a successful and safe relocation of the active stock from the alternative Depot provider.
We also manage projects with cytotoxic products, antibiotics, highly active substances that are distributed through several countries of EAEU. SMO-Russia has performed additional labelling under amber tinning, organized building of treatment kits and direct-to-site supplies bypassing depot.
There are a lot of unique competences that we have here locally, but I want to assure you that our current team is fully build and properly trained and can fulfil any logistics requirements of the clients.
What would you advise to pharmaceutical companies who are interested in running clinical trials in Russia?
Plan properly and agree on everything in advance, carefully choose partners while properly balancing reliability and cost of the services, be in line with the recent regulatory changes.