October 29, 2009 14:57 ET

bioRASI to Exhibit at the 2009 AAPS Annual Meeting in Los Angeles, CA

The Leading ANDA and 505(b)(2) CRO to Showcase Techniques on Reducing Variability of Clinical Endpoint Trials

HOLLYWOOD, FL--(Marketwire - October 29, 2009) - bioRASI, a full service, global Contract Research Organization (CRO), announced today that they will participate in the 2009 AAPS Annual Meeting and Exposition in Los Angeles, CA on November 8 - 12th. bioRASI will be exhibiting at booth #757 and will showcase its strategies and solutions to overcome the challenges within ANDA and 505(b)(2) clinical endpoint studies.

"bioRASI has emerged as the leader in conducting clinical endpoint ANDA and 505(b)(2) studies," said Dr. Boris Reznik, Chairman of bioRASI. "It is not only because of the high quality of our managed trials and our unique access to required patients, but also because of our focus on implementing techniques that minimize trial induced variability. Even with just one percentage point reduction in the standard deviation of an endpoint, the probability of the trial's success increases by several percentage points."

Pivotal Clinical Endpoint Trials for ANDA and 505(b)(2) submissions are normally multicenter trials requiring many hundreds of patients. Naturally they are much more expensive and longer in duration than PK trials, and therefore anything that can increase the probability of the trial's success is extremely important.

bioRASI has been applying a number of techniques that have been proven to reduce trial induced variability. This includes careful selection of the clinical endpoints and their measurement scales, tools and techniques. Coupled with proprietary, interactive clinical personnel training, these techniques maximize consistency in the measurements of the clinical endpoints across multiple sites.

To help control external variables, bioRASI performs proprietary subject training on dosing and other aspects of the protocol (sometime including a "placebo lead-in period"), with a keen focus on maintaining discipline and consistency. bioRASI's unique access to the targeted patient populations allows for the optimization of treatment group size per center, another component of consistency.

"Our very tight focus on CE ANDA and 505(b)(2) trials has been embraced by the Generic and Specialty Pharmaceuticals Industry," added Dr. Thomas Ichim, bioRASI's Chief Scientific Officer. "Sponsors welcome our ever-growing expertise in optimizing CE trial programs, making bioRASI the number one CRO in the ANDA and 505(b)(2) industry."

About bioRASI

bioRASI is a Full Service Global CRO uniquely focused on clinical endpoint ANDA and 505(b)(2) programs. This experience and expertise allow bioRASI to facilitate obtaining FDA approvals by delivering high quality regulatory and clinical strategies, solutions and services, while saving their clients critical time. bioRASI's services include program management, regulatory, clinical, data management and analysis, compliance and audit. bioRASI leverages its unique access to the world's largest facilities and patient populations 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 across the globe.

Contact Information