HOLLYWOOD, FL--(Marketwire - March 16, 2009) -
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bioRASI |
"bioRASI has developed into a powerful full service global CRO that is specifically focused on ANDA, 505(b)(2) NDA and the Translational Stage of Innovative Therapeutics programs," said Dr. Boris Reznik, Chairman of bioRASI. "Our Indian operations joined our very formidable North American and Eastern European operations, and with our greater involvement in South America, we now have a tremendous range of capabilities to help us optimize the cost and time of clinical development programs for our sponsors."
Through its Innovative and Generics divisions, bioRASI leverages its in-depth knowledge and global resources to provide a full range of services to its sponsors, including program management, regulatory strategy design and implementation, clinical development, analytical lab services, Part 11 compliant data management, data analysis and report writing.
bioRASI has leveraged its unique global access to strong PIs and special patient populations to optimize translational clinical development programs. Additionally, utilizing bioRASI's Phase I clinics and bioanalytical laboratories, bioRASI has a rich history of completing difficult to recruit and difficult to perform PK, BE and BA studies.
"As the Translational Clinical Development CRO, we can advance candidates from IND enablement through Proof of Concept, Phase II trials, expeditiously and cost effectively," said Gary W. Thompson, bioRASI's Vice President of Business Development. "With access to thousands of subjects in a number of categories, we have become leaders in difficult to recruit, difficult to perform innovative therapeutics studies."
About bioRASI
bioRASI is a Full Service Global CRO that collaborates with the leading
biotech and pharmaceutical companies in the clinical development of novel
and generic therapeutics. Specializing in Innovative, ANDA and 505(b)(2)
NDA programs, bioRASI facilitates obtaining FDA approvals by delivering
high quality regulatory and clinical strategies, solutions and services,
while saving their clients critical time. bioRASI services include program
management, regulatory, clinical, data management and analysis, compliance
and audit. bioRASI leverages its access to world renowned researchers and
facilities in the U.S., Europe and Asia, to achieve unparalleled
scientific, clinical and business results at significantly lower costs.
bioRASI is headquartered in Hollywood, FL and has regional offices, labs,
and clinics across the globe.
