<0> ClinStar Execs Leon Dzivinsky and Richard Koenig to Examine How Clinical Study Start-Up Timelines Compare in Emerging Markets and How Biopharm Can Mitigate Risks and Reduce Timelines in Russia </0>
ClinStar to Host Live Webinar on Clinical Study Start-Up across Emerging Markets with Emphasis on Russia
ClinStar LLCHeather Newbold, 919-354-3573 ext. 276
, an established clinical research organization providing clinical development services in the emerging markets of Russia and Eastern Europe to the pharmaceutical and biotechnology industry, announced today that they will host a live webinar September 13, 2012 entitled “”
“The biopharmaceutical industry is facing unprecedented pressure to fill thinning pipelines while operating under constrained R&D budgets,” says ClinStar/IMP Logistics Senior Vice President and General Counsel Leon Dzivinsky. “Emerging markets offer a great opportunity for pharmaceutical and biotechnology companies to reduce their clinical trial timelines, and therefore costs, by providing access to large treatment-naive patient populations and much higher patient enrollment rates. Study start-up regulations differ in these markets, however, so it is important to understand how these requirements impact start-up timelines and global study planning.”
During the webinar, Mr. Dzivinsky and Vice President Business Operations Richard Koenig will review and compare the advantages and disadvantages of conducting clinical trials in several major emerging markets and examine how study start-up timelines in these countries differ and impact the decision-making process when selecting geographies for a global clinical trial. Mr. Dzivinsky will close the discussion with a review of the major regulatory challenges that can be anticipated when starting up a trial in Russia, such as clock stoppages, import/export licensing, legal representation and contract negotiations.
ClinStar is one of the most prominent clinical research organizations in the emerging markets of Eastern Europe and the Baltics with more than 10 years of expertise in Phase I-IV clinical development in multiple therapeutic areas. Headquartered in San Francisco, California, ClinStar manages clinical trials from its offices in Russia, Ukraine and Belarus, with total staff of over 260 people. Its portfolio contains over 130 clinical trials conducted for US and European pharmaceutical and biotechnology companies. More information is available at .