iCardiac Technologies, Inc., a global leader in advanced cardiac core lab services and QT analysis, announced today that a top five pharmaceutical company has awarded iCardiac a comprehensive "Thorough QT" (TQT) study. iCardiac will provide end-to-end study management, international equipment deployment and scientific reporting, as well as advanced ECG analytics. The study will utilize iCardiac's Highly Automated QT and Dynamic QT beat-to-beat(sm) service offerings to dramatically improve study precision and reduce false positives and negatives.
"iCardiac's ability to reduce sample size as well as false positives in TQT studies continues to be well received by the pharmaceutical industry," said Sasha Latypova, Executive Vice President. "As these methods are now accepted as part of the regulatory review of cardiac safety, we expect the speed of adoption to continue to accelerate."
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.
Source: EARTH TIMES
Pharmaceutical Process Equipment
