FDA News

Global Research Services and CardioDynamics Global Research Services Sign Strategic Alliance Agreement

(March 18, 2008)-- Global Research Services, LLC (GRS) entered into a strategic alliance with CardioDynamics. The agreement authorizes GRS to utilize CardioDynamics’ impedance cardiography (ICG) technology for advanced processing of noninvasive hemodynamic ICG data. CardioDynamics ICG products enable GRS to provide expanded biometrics and data management services in support of clinical trials. Combining the strengths of both companies will allow biotechnology, pharmaceutical, and device companies and clinical research sites to obtain the benefits of enhanced cardiac safety monitoring in Phase I through IV clinical trials.

GRS has recently completed several programs using this state of the art technology to rapidly upload data from CardioDynamics’ proprietary BioZ ICG technology and BioZport® application software. Investigators and sponsors can easily view reports and detailed cardiovascular tables and graphs created from real-time trial data through secure online portals, assisting in faster decisions related to dose selection, safety outcomes, and therapeutic efficacy of cardio-active agents.

CardioDynamics’ proprietary BioZport application software was designed to meet FDA’s 21 CFR Part 11 and HIPAA requirements and provides real-time transmission of ICG data for rapid assessment of both desired and adverse effects of candidate compounds. With the increasing focus of regulatory agencies on cardiac safety assessment of new compounds, CardioDynamics and GRS are pleased to provide this enhanced capability to the clinical trial market.

Dr. Sandra Garrett, Executive Chair, GRS said, “This technology, coupled with our Oracle Clinical data management capabilities clearly elevates the capability of cardiac safety monitoring and evaluation in research settings.”

Michael K. Perry, CEO, CardioDynamics, added “We are very pleased to partner with GRS and believe that their data management capabilities, their highly regarded reputation in clinical research, as well as extensive global experience make them an excellent strategic alliance partner. With the recent challenges of FDA-approved drugs having serious cardiac side effects, including death, we believe this is an ideal application for our proprietary technology.”

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