Study Utilizes Highly Automated QT(sm) and QT Beat-to-Beat(sm) to Improve Precision and Reduce Risk of False Positives/Negatives
Rochester, NY (PRWEB) September 16, 2009 -- iCardiac Technologies, Inc., a leader in advanced cardiac core lab services and QT analysis, announced today that a top 15 pharmaceutical company has awarded iCardiac a comprehensive 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 both iCardiac's Highly Automated QT and QT beat-to-beat offerings to dramatically improve study precision, as well as to reduce the likelihood of false positive or false negative findings.
"We are pleased that the industry continues to recognize the scientific and business value of iCardiac's end-to-end solutions for Phase I through Phase IV studies," said Sasha Latypova, Executive Vice President. "To date iCardiac has performed more cardiac safety studies using automated QT methods than all other commercial ECG core laboratories, making iCardiac the clear leader in the next generation of advanced cardiac safety services."
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 has been validated by pharmaceutical companies and is now used in regulatory submissions as being equivalent to the manual evaluation of ECGs in Thorough QT studies. In addition, iCardiac provides Beyond QT, 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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