Service Offerings Include Highly Automated QT(sm) and QT Beat-to-Beat(sm) to Improve Precision and Reduce Risk of False Positives/Negatives
Rochester, New York (PRWEB) January 8, 2010 -- iCardiac Technologies, Inc., a leader in advanced cardiac core lab services and QT analysis, announced today that a leading global CRO has selected iCardiac as a preferred vendor of cardiac safety services. iCardiac will provide end-to-end study management, international site logistics and scientific reporting, as well as advanced ECG analytics. The agreement includes iCardiac’s Highly Automated QT and QT beat-to-beat offerings for dramatically improving study precision, as well as reducing the likelihood of false positive or false negative findings in critical safety studies.
"We are pleased that the industry continues to recognize the scientific and business value of iCardiac’s technical solutions and core lab services in cardiac safety studies,” said Sasha Latypova, Executive Vice President. "Following a strong 2009, we are pleased to start 2010 with a continuation of the rapid adoption of iCardiac’s Highly Automated QT and Dynamic QT beat-to-beat solutions."
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 global cardiac core lab providing the industry’s most sophisticated ICH E14 compliant 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: www.icardiac.com.
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