Rochester, NY (PRWEB) September 24, 2009
iCardiac Technologies, Inc., a leader in advanced cardiac core lab services and QT analysis, announced today that a leading biotechnology company has awarded iCardiac a multi-center international Phase III cardiac safety study. iCardiac will provide end-to-end study management, site logistics and scientific reporting, as well as advanced ECG analytics. The study will utilize iCardiac's Highly Automated QT(sm) to dramatically improve study precision.
"We are pleased that the industry continues the rapid adoption of iCardiac's automated QT methods, which have demonstrated superiority to traditional manual or semi-automated ECG evaluation," said Sasha Latypova, Executive Vice President. "With this contract award, iCardiac continues its clear scientific and market leadership for automated QT studies with a larger number of studies completed or contracted than other commercial ECG core laboratories."
In October 2005, the FDA introduced a new guidance for industry (ICH E14) requiring the evaluation of pro-arrhythmic potential of new drugs by measuring the QT segment of ECGs collected in clinical trials. The dissatisfaction among pharmaceutical developers with the poor precision, high rate of false positives/negatives and high cost of the "gold standard" manual or semi-automated QT measurements has lead to efforts toward providing more advanced cardiac safety analytics.
About iCardiac Technologies
iCardiac Technologies, Inc. is a technologically-differentiated cardiac core lab providing the industry's most sophisticated FDA-accepted cardiac safety assessment methodologies for Phase I through Phase IV studies, supported by expert scientific consultation, end-to-end project management, worldwide site and equipment logistics, 24/7 customer support and regulatory data submission. iCardiac's analysis services provide drug developers with more precise and cost-effective methods for ECG interval measurements, including Highly Automated QT, which is the market leading solution for automated evaluation of QT intervals for regulatory submissions. In addition, iCardiac provides Beyond QT(sm), a suite of advanced ECG-based cardiac safety markers that have been accepted and used as a secondary end-point in regulatory approvals, and which delivers a more accurate assessment of the cardiac safety profile of drugs in development. iCardiac's COMPAS technology has been used for over a decade in cardiac clinical trials conducted for and by leading large and medium sized pharmaceutical, biotechnology and medical device companies. For more information, visit: http://www.icardiac.com.