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Clinical Trials in Russia. 2nd Quarter 2007

According to SynRG Orange Paper, In the 2nd Quarter of 2007, The Federal Agency for Health Care and Social Development (Roszdravnadzor, or RZN) issued 114 permits to conduct clinical trials in Russia. This is 13% as low as in the second Quarter last year; at the same time, the number of international multi-center clinical trials became 25% as low, and the number of local and bioequivalence studies grew inconsiderably.

On July 25, 2007 Synergy Research Group (SynRG), a Russia-based CRO, presented the current issue of its Orange Paper, a regular analytical report on the market of clinical trials in Russia. The report contains hundreds of figures as well as 11 Tables and 9 Pictures covering various aspects of the Russian Clinical Trials market. This is another step to formation of a civilized market of clinical trials in Russia and improvement of the research attractiveness of Russia for foreign sponsors – few of the key strategic objectives of Synergy Research Group.

As a result, the contribution made by Russian sponsors grew by 7% as compared to the second Quarter of 2006 and made up 35% of the total volume of the clinical trials market in Russia. Study sponsors were 72 companies from 23 countries including Russia, which was represented by 22 companies. The leader among foreign countries participating in the clinical trials market is the US (17%) followed by Switzerland (11%) and Germany ranking third with its 7%.

As many as 284 medical institutions will take part in trials initiated in the 2nd Quarter of 2007, which is just over one third of the total number of study sites accredited by RZN for conducting clinical trials. Over 50% of them are located in Moscow and Saint-Petersburg, which is another confirmation of the unequal usage of regional clinical sites. Over 10,000 patients will take part in the trials, and the average trial duration will be 19 months.

The leader among foreign sponsors is Hoffmann-La Roche (10 clinical trials, 89 sites and 1,042 patients), and the leader among Russian sponsors is ZAO Severnaya Zvezda (The Northern Star).

In the 2nd Quarter of 2007 FDA approved 27 new drugs with four of them being tested in clinical trials in Russia. During the same period, the European Medicine Agency (EMEA) approved of 43 marketing applications for drugs with six of them also being or having been tested in clinical trials in Russia.

In the 2nd Quarter of 2007 RZN inspectors conducted 12 regular audits of clinical trial quality and accredited 18 new study sites. FDA carried out five inspections in the territory of Russia for the first six months; in three cases, it reported on NAI (No Action Indicated), and in other cases – on VAI (Voluntary Action Indicated).

Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating all over Russia and the CIS member-states since 2002. SynRG™ offers a broad range of services for conducting clinical trials for Russian and foreign pharmaceutical and biotechnological companies – from registration of the studies in regulatory authorities to pharmaco-economic surveys. The company has its own clinical warehouse in Moscow, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg and Almaty. The company’s headquarters are in Moscow.




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