SAN FRANCISCO--(ClinStar, LLC, 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 present on “Study Start-Up: A Comparison Across Emerging Markets with Emphasis on Russia” at the Outsourcing Clinical Trials New England conference September 25-26 in Boston. As a follow-up, ClinStar will host an educational seminar September 27 at the Hyatt Regency in Cambridge entitled, “Optimizing Time and Money in Clinical Trials: A Russian, Ukrainian and Eastern European Perspective.”)--
“Emerging markets such as Russia and Eastern Europe have become widely accepted by the biopharmaceutical industry as ideal locations for conducting clinical trials due to their high enrollment rates, experienced investigators and centralized healthcare systems”
“Emerging markets such as Russia and Eastern Europe have become widely accepted by the biopharmaceutical industry as ideal locations for conducting clinical trials due to their high enrollment rates, experienced investigators and centralized healthcare systems,” says ClinStar/IMP Logistics Senior VP and General Counsel Leon Dzivinsky. “Despite these advantages, however, many biopharmaceutical companies still have negative perceptions of working in this region due to fear of prolonged study start-up times and unknown regulatory and logistics requirements.”
During the Outsourcing in Clinical Trials presentation scheduled for Tuesday September 25 at 11:30 am ET, Mr. Dzivinsky and VP Business Operations Richard Koenig will review the advantages and disadvantages of conducting clinical trials in emerging markets and examine how study start-up regulations and timelines impact the decision-making process when selecting geographies for a global clinical trial. Mr. Dzivinsky will also review some of the regulatory challenges that can be anticipated when starting up a trial in Russia, including clock stoppages, import/export licensing, legal representation and contract negotiations. Following the conference, ClinStar will sponsor an educational seminar at the Hyatt Regency Cambridge on September 27 at 3:00 pm ET entitled, “Optimizing Time and Money in Clinical Trials: A Russian, Ukrainian, Eastern European Perspective.” During the seminar, we will:
- Examine if biopharmaceutical companies are saving time and money by conducting clinical trials in Russia, Ukraine and Eastern Europe
- Evaluate if data from the trials being conducted in this region are being included in FDA and EMEA drug approvals
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 www.clinstar.com.