SOURCE: bioRASI

November 27, 2007 17:47 ET

bioRASI to Exhibit at the 10th Annual IGPA Conference in Miami Beach, Florida

A Leading CRO in Dermal Clinical Development Programs to Unveil Its New Patent-Pending Rater Training Methodology

HOLLYWOOD, FL--(Marketwire - November 27, 2007) - bioRASI announced today that it will participate in the 10th Annual International Generic Pharmaceutical Alliance (IGPA) Conference in Miami Beach, FL on Nov 28th - Dec 1st. bioRASI will be exhibiting at booth #6 and will showcase its Generics Division capabilities that are focused on ANDA and 505(b)(2) programs. bioRASI will unveil its new rater training methodology, recently released for clinical studies of dermatology products.

"Our leadership in the area of dermal clinical development programs has advanced through the use of our new, patent-pending methodology that significantly improves intra- and inter-rater variability in clinical studies involving dermal measurements," said Dr. Reznik, Chairman of bioRASI. "The evaluation of skin conditions has always been challenging due to the high variability of results among PIs and raters, especially in multi-site studies. Our new methodology is contributing to making these studies more efficient."

As a global CRO, bioRASI provides a full range of services required by ANDA and 505(b)(2) NDA applications, including program management, regulatory strategy design and implementation, clinical development, analytical lab services, Part 11 compliant data management, data analysis and report writing.

"We are excited about bioRASI's new methodology that helps to optimize Generics and 505(b)(2) Dermal clinical development programs requiring clinical equivalency, efficacy or dermal safety studies," said Dr. Maguire, bioRASI's program director. "In addition, our unique access to special subject populations, and our proven capabilities in PK/BE/BA studies, allow us to achieve unparalleled success for our generic and 505(b)(2) clients."

About bioRASI

bioRASI, the translational clinical development CRO, is focused on managing and optimizing the progression of lab candidates through clinical proof of efficacy and safety. bioRASI's Innovative Division helps companies bring their candidates from IND enablement through Phase II clinical proof studies and its Generics Division focuses on the translation of the candidate through pilot and pivotal clinical studies. bioRASI leverages its full service capabilities and global resources to achieve unparalleled scientific, clinical and business results for its sponsors. bioRASI is headquartered in Hollywood, FL and has regional offices, labs, and clinics across the globe.

Contact Information