We are proud to be able to respond rapidly to the needs of the world’s leading pharmaceutical and biotechnology companies, especially as they demand improved platforms for conducting global cardiac safety studies.
Rochester, N.Y. (PRWEB) March 11, 2010
iCardiac Technologies, Inc., a leader in advanced cardiac core lab services and QT analysis, announced today that a top 10 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. This Phase I study will utilize both iCardiac’s Highly Automated QT and QT beat-to-beat solutions to dramatically improve study precision, as well as to reduce the likelihood of false positive or false negative findings.
“The transition to more reliable techniques for assessing cardiac safety continues to accelerate,” said Sasha Latypova, Executive Vice President. “More importantly, the return on investment of a more robust and precise cardiac safety characterization in Phase I trials is beginning to be recognized. We are proud to be able to respond rapidly to the needs of the world’s leading pharmaceutical and biotechnology companies, especially as they demand improved platforms for conducting global cardiac safety studies.”
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 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 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: http://www.icardiac.com.