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bioRASI Expands Compliance and Audit Group
MIAMI, FL - (MARKET WIRE) - 03/01/2006 - In response to sponsor needs as well as the increasingly stringent demands of the FDA and international regulatory bodies for ICH-GCP adherence, bioRASI announced today the expansion of its Compliance and Audit Group into a Services Branch.
With this move, bioRASI has substantially augmented its abilities to act as a third-party auditor for ongoing clinical trials. Specifically, bioRASI will integrate its trans-national and trans-disciplinary expertise and add a substantial number of dedicated staff. Currently, bioRASI is performing compliance audits at sites, clinical laboratories, and data management facilities for ongoing clinical trials across the globe from Eastern Europe and Asia to North America.
"Clinical trials are proliferating in locations outside the United States, and with the increased diversity of clinical sites and Principal Investigators, it is becoming more and more important for sponsors to ensure the universal application of the standardized guidelines set forth by ICH-GCP," said Dr. Boris Reznik, Chairman of bioRASI. "Our Compliance and Auditing Services Branch is uniquely equipped to provide FDA and other regulatory audits in a uniform and cohesive manner."
The newly expanded Compliance and Audit Services Branch joins bioRASI's extensive list of currently available services, including program management, regulatory services, clinical and data management and analysis. With co-headquarters in Miami, Florida and Moscow, R.F., bioRASI is able to provide auditing services in the Americas and throughout Europe, Asia and the countries of the former Soviet Union.
bioRASI is a full service global CRO uniquely positioned to provide optimized pipeline developmentTM to biotechnology and pharmaceutical companies. A strategic initiative of the 250,000 person-strong Russian Academy of Sciences, bioRASI conducts research throughout the Americas, Europe, and Asia. bioRASI is experienced in biologicals, medical devices, and small drugs across a wide range of indications, maintaining equal balance between Pilot, Phase I/BE, and Phase II/IV studies. Applying these capabilities, bioRASI is able to significantly expand and accelerate the development of its clients' therapeutics pipelines. bioRASI is co-headquartered in Miami, FL and Moscow, R.F., and has regional offices across the globe.