Rochester, NY (PRWEB) October 04, 2011
iCardiac Technologies, Inc., a provider of next generation cardiac core lab services, announced today it has been awarded four global respiratory studies. iCardiac will provide centralized cardiac safety services for a late stage program for a leading biotech company, to be conducted in the United States, Europe, and Australasia. iCardiac’s international service footprint, deep medical expertise, and differentiated technology offering played a key role in securing the studies.
“We are excited about the continued growth of iCardiac’s portfolio of complex global late stage studies,” said Sasha Latypova, executive vice president. “We are proud to deliver a set of solutions for improving precision, accuracy and resource efficiency for cardiac safety evaluation.”
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, was originally developed and validated at the University of Rochester’s Heart Research Follow Up Program, 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.
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