Rochester, NY (PRWEB) September 08, 2011
iCardiac Technologies, Inc., a provider of next generation cardiac core lab services, announced today it has become a member of the Cardiac Safety Research Consortium (CSRC). As a member, iCardiac will collaborate with the CSRC to contribute methods for improving the assessment of cardiac safety in clinical trials.
“We look forward to partnering with the CSRC and contributing our expertise to improving the current approaches to cardiac safety testing,” said Sasha Latypova, executive vice president. “We share the CSRC’s mission of bringing forward the best available science for determining the arrhythmia liability of compounds in clinical development.”
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 precision, rate of false positives/negatives and high cost of manual or semi-automated QT measurements has led to efforts toward providing more advanced cardiac safety analytics.
About iCardiac Technologies
iCardiac Technologies, Inc., provides drug development companies worldwide with a complete range of next generation cardiac safety core lab services. Its team of cardiac safety experts collectively bring over 100 years of cardiology, electrophysiology, drug development, regulatory and academic experience. iCardiac pioneered the use of High Precision QT evaluation as well as proprietary methodologies controlling for autonomic nervous system effects on the QT interval, a phenomenon estimated to produce false-positive results in conventional QT studies for as many as 25% of all molecules currently in clinical development. iCardiac’s services are supported by the COMPAS technology platform which maximizes the precision and decreases the cost of cardiac safety assessment from First-in-Human studies to Phase III studies. This suite of tools, which complies with the FDA’s ICH E14 QT/QTc guidance for Through QT Studies (TQT), was originally developed and validated at the University of Rochester’s Heart Research Follow Up Program (HRFUP), as well as in Pfizer’s Research and Development programs. iCardiac’s analytics have been used for over a decade in support of clinical trials.