HOLLYWOOD, FL -- 10/29/09 --
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
Lindsey Hall
(786) 388-0700
Email Contact
www.biorasi.com