Clinical Trials in Russia. 1st Quarter 2009
On June 01, 2009 Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q1 2009, a regular analytical report on the clinical trial market in Russia. The report is Free and contains hundreds of figures as well as dozens of tables and pictures covering various aspects of the Russian clinical trial market.
Moscow, Russia, June 03, 2009 --(PR.com)-- On June 01, 2009 Synergy Research Group (SynRG), a Russia-based CRO, presented the English version of SynRG Orange Paper Q1 2009, a regular analytical report on the clinical trial market in Russia. The report contains hundreds of figures as well as dozens of tables and pictures covering various aspects of the Russian clinical trial 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, one of the SynRG’s key strategic goals.
The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 113 new clinical trials during Q1 2009, a 13% decrease over the corresponding period of last year.
Clinical trials in Russia in Q1 2009 were sponsored by companies from 28 countries. The maximum number of trials (31) was initiated by Russian sponsors, American sponsors with 20 studies took the runner-up place, they are followed by the German sponsors with 12 trials, the same number of 8 new trials was instigated by the Swiss and Japan companies, and the top six is concluded by the UK sponsors with 7 new studies in Q1 2009.
Four new Phase I studies were launched in the first quarter of 2009; three trials less than in the corresponding quarter of last year. The number of the Phase II trials notably decreased from 41 trials in the first quarter of 2008 to 26 in the first quarter of 2009. Despite the overall trend, the number of Phase III trials demonstrated slight increase over last year number, up from 54 to 59 studies. The number of Phase IV trials slightly decreased from twelve in Q1 2008 to nine new studies in Q1 2009.
The number of patients which are planned to be enrolled in the Phase II-IV trials launched in the first quarter of 2009 stood at 9,784 patients, nearly the same as the last year number.
The German Boehringer Ingelheim sponsoring seven new studies is on the top
of the heap in the first quarter of 2009. The Swiss Novartis with seven new trials in Q1 2009, but fewer number of patients, took the runner-up place, it is followed by American Pfizer with six new studies, and Merck & Co. with four new. The top five is concluded by German Hexal Biotech with three new studies in Q1 2009.
The Russian pharmaceutical company OOO Pharmaclon sponsoring two new clinical trials enrolling 140 patients in two sites, ranked number one among domestic pharmaceutical manufacturers by the number of new studies in the first quarter 2009. OAO Valenta Pharmaceutica with two new trials and 105 subjects in four sites, took the runner-up place. It is followed by FGU Russian Cardiologic Center and ZAO Biocad. The fifth position is shared between OAO Biosyntez and ZAO Vector-Medica.
Seventy per cent of the new studies in Q1 2009 were conducted in six therapeutic areas. The maximum number of trials (17) were initiated in Cardiovascular diseases; 16 clinical trials in Neurology and Oncology; 14 studies were targeted at Infectious diseases; 12 – in Respiratory diseases and 11 endocrinological studies were initiated in Q1 2009.
Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating in Russia 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 depot in Moscow, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm and Almaty (Kazakhstan). The company’s headquarters are in Moscow.
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The Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN) approved 113 new clinical trials during Q1 2009, a 13% decrease over the corresponding period of last year.
Clinical trials in Russia in Q1 2009 were sponsored by companies from 28 countries. The maximum number of trials (31) was initiated by Russian sponsors, American sponsors with 20 studies took the runner-up place, they are followed by the German sponsors with 12 trials, the same number of 8 new trials was instigated by the Swiss and Japan companies, and the top six is concluded by the UK sponsors with 7 new studies in Q1 2009.
Four new Phase I studies were launched in the first quarter of 2009; three trials less than in the corresponding quarter of last year. The number of the Phase II trials notably decreased from 41 trials in the first quarter of 2008 to 26 in the first quarter of 2009. Despite the overall trend, the number of Phase III trials demonstrated slight increase over last year number, up from 54 to 59 studies. The number of Phase IV trials slightly decreased from twelve in Q1 2008 to nine new studies in Q1 2009.
The number of patients which are planned to be enrolled in the Phase II-IV trials launched in the first quarter of 2009 stood at 9,784 patients, nearly the same as the last year number.
The German Boehringer Ingelheim sponsoring seven new studies is on the top
of the heap in the first quarter of 2009. The Swiss Novartis with seven new trials in Q1 2009, but fewer number of patients, took the runner-up place, it is followed by American Pfizer with six new studies, and Merck & Co. with four new. The top five is concluded by German Hexal Biotech with three new studies in Q1 2009.
The Russian pharmaceutical company OOO Pharmaclon sponsoring two new clinical trials enrolling 140 patients in two sites, ranked number one among domestic pharmaceutical manufacturers by the number of new studies in the first quarter 2009. OAO Valenta Pharmaceutica with two new trials and 105 subjects in four sites, took the runner-up place. It is followed by FGU Russian Cardiologic Center and ZAO Biocad. The fifth position is shared between OAO Biosyntez and ZAO Vector-Medica.
Seventy per cent of the new studies in Q1 2009 were conducted in six therapeutic areas. The maximum number of trials (17) were initiated in Cardiovascular diseases; 16 clinical trials in Neurology and Oncology; 14 studies were targeted at Infectious diseases; 12 – in Respiratory diseases and 11 endocrinological studies were initiated in Q1 2009.
Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating in Russia 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 depot in Moscow, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm and Almaty (Kazakhstan). The company’s headquarters are in Moscow.
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Synergy Research Group
Igor Stefanov
+7 495 643 1186
www.synrg-pharm.com
Igor Stefanov
+7 495 643 1186
www.synrg-pharm.com
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