Navigation Links
Top 10 Pharmaceutical Company Awards Comprehensive Cardiac Safety Study to iCardiac
Date:3/11/2010

iCardiac Continues Technology Leadership with Largest Number of Highly Automated QT(sm) and QT Beat-to-Beat(sm) 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: www.icardiac.com.

###

Read the full story at http://www.prweb.com/releases/automated/qt/prweb3699974.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved

Related medicine news :

1. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
2. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
3. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
4. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
6. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
8. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
9. Par Pharmaceutical Files Form 10-K for 2006 -- Company to Hold First Analysts Meeting September 28, 2007
10. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
11. Pharmaceutical Manufacturing Quality: Optimizing Your Internal Process for FDA Compliance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance Group, a ... Miami, and Raleigh regions, is organizing an extended charity drive to benefit the ... chromosome abnormality. , After struggling since birth with several health challenges, T.J. was ...
(Date:10/13/2017)... IL (PRWEB) , ... October 13, 2017 , ... ... which established the certification process to promote standards of excellence for the field ... Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at the ...
(Date:10/13/2017)... ... 2017 , ... Many families have long-term insurance that covers care for a ... waiver for care if the client has a cognitive impairment diagnosis. , “What ... is often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob Lowe, ... in a new episode of "Success Files," which is an award-winning educational program ... investigates each subject in-depth with passion and integrity. , Sciatica occurs when the ...
(Date:10/12/2017)... CA (PRWEB) , ... October 12, 2017 , ... ... Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent technology. ... a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, Inc. ... Day Software and Consulting, LLC , and named its ... Software, based in Tennessee , will ... Day expands EnvoyHealth,s service offerings for health care partners ... "In an interoperable world, ...
(Date:10/2/2017)... Fla. , Oct. 2, 2017  AllianceRx Walgreens ... company formed by Walgreens and pharmacy benefit manager Prime ... its new brand, which included the unveiling of new ... , as well as at a few other ... the new brand to patients, some of whom will ...
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile app ... struggle to reverse the tide of prescription drug addiction. The ... their medicine intake and stepping down their dosage in a ... launch in December 2017; the first 100,000 people to sign ... at http://www.rebound-solution.com/ ...
Breaking Medicine Technology: