San Francisco, CA (June 09, 2010) – ClinStar, a leading Western CRO in Russia, Ukraine, Belarus and the Baltic States, announced its first steps in adding clinical operations capacity in the United States. ClinStar entered into contractual relationships with Mr. Stephen Fogelson, M.S. to assist ClinStar in running the US portions of the global studies for ClinStar’s Sponsors. This partnership will boost ClinStar’s geographical reach by adding US sites to the successful and well-established business in Russia, Ukraine and other parts of Eastern Europe.
On assignment with ClinStar, Mr. Fogelson will manage full spectrum of clinical activities in the United States including site identification, qualification, monitoring, project and site management, etc. Clinical operations will be carried out in accordance with ClinStar SOPs, harmonized with US regulations.
Mr. Fogelson is a distinguished expert in clinical research and development, with over 20 years of experience in the industry. For the last 5 years Mr. Fogelson has been providing extensive strategic and tactical consultancy services to pharmaceutical and biotech companies. Mr. Fogelson commented: “I am very excited about this opportunity. ClinStar clearly understands global needs of the industry with a great balance of cost, speed and quality."
“I am very proud that ClinStar is entering its second decade with such a tremendous advancement,” said David Passov, President and CEO of ClinStar. “After providing our clients with 10 years of the highest quality of service and dedication in our regions, this expansion marks an important progress in our service offerings. By adding clinical operations capabilities in the US, ClinStar significantly enhances its abilities for servicing clients in need of full-range service offering for their FDA and EMEA registration studies. By expanding our capabilities into US, we will become a global provider while retaining ClinStar’s core value of local expertise, and we will continue to provide faster patient enrollment, extraordinarily high quality and unsurpassed focus on every client."
ClinStar is now offering its clients a full-range of clinical trial solutions including clinical and regulatory affairs, medical monitoring, QA auditing, as well as study materials logistics, warehousing and distribution.
About ClinStar: ClinStar is one of the most prominent CROs in emerging markets of Eastern Europe and the Baltics, with 10 years of expertise in Phase I-IV clinical studies in multiple therapeutic areas. Headquartered in San Francisco, California, ClinStar manages studies from its offices in Russia, Ukraine, Belarus, and Estonia, with total staff of over 280 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