Navigation Links
Top Five International Pharmaceutical Company Awards Comprehensive Cardiac Safety Study to iCardiac
Date:11/11/2009

Positions iCardiac as technology leader in global ECG core lab market with largest number of highly automated QT(sm) studies.

Rochester, NY (PRWEB) November 11, 2009 -- 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.

About iCardiac Technologies
iCardiac Technologies, Inc. is a technologically-differentiated global 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 is the market leading solution for automated evaluation of QT intervals for regulatory submissions. In addition, iCardiac provides Beyond QTsm, 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/thorough_qt/prweb3116734.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved

Related medicine news :

1. Tyco International Reports Fourth Quarter Earnings From Continuing Operations Before Special Items of $0.61 Per Share and GAAP Earnings of $0.44 Per Share
2. Phoenix House Appoints Dr. Deni Carise as Chief Clinical Officer - Internationally Recognized Leader in Substance Abuse Treatment and Research
3. Tyco International to Present at the Citi Industrial Manufacturing & Transportation Conference
4. AirMed International, Top U.S. Air Ambulance, Receives EURAMI Accreditation
5. HUYA Bioscience International Establishes Strategic Partnership with School of Medicine and Pharmacy, Ocean University of China
6. Allied Worlds Nicole Baummer and Marjorie Thompson to Speak at PLUS International Conference
7. Service Corporation International Announces Third Quarter 2009 Financial Results
8. Stenum Hospital Kicks off International Rollout of M6 Artificial Lumbar Disc Replacement Surgery
9. FDA CONSUMER HEALTH INFORMATION UPDATES: Fraudulent H1N1 flu products, hearing aids, sound amplifiers, tobacco regulation, FDAs international posts, LASIK eye surgery, and FDA MedWatch safety alerts
10. Service Corporation International Announces Schedule for Its Third Quarter 2009 Earnings Release and Conference Call
11. Blue Cross and Blue Shield of Floridas Power of the Human Voice Campaign Wins Prestigious DMA International ECHO Gold Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... According to ... In an industry filled with chemical-laden beauty products, one company is going against the ... for you: Mad Hippie. The rising star in the green space is proud to ...
(Date:5/26/2016)... Lake MN (PRWEB) , ... May 26, 2016 , ... ... Stance Angle chair , furniture that may support women during pregnancy. Potential benefits ... legs and feet, improved rest and comfort and healthier levels of sitting and standing. ...
(Date:5/25/2016)... (PRWEB) , ... May 26, 2016 , ... The United ... treatment of androgenetic alopecia in both men and women. To date, the company is ... with FDA clearance for any adult who suffers with androgenetic alopecia. , “This ...
(Date:5/25/2016)... ... May 25, 2016 , ... “We ... Managing Partner at HealthScape Advisors. “Brad brings significant experience advising healthcare provider clients ... system accelerates with the implementation of MACRA, we believe that continuing to add ...
(Date:5/25/2016)... Kansas City, MO (PRWEB) , ... May 25, 2016 , ... ... professional, collegiate, and amateur athletics, The National Center for Drug Free Sport (Drug Free ... Drug Free Sport”. This conference, to be held July 12 – 13 in Kansas ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... , Germany and ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt Prime ... a licensing and co-development agreement with Therawis Diagnostics GmbH to ... will be to develop and market PITX2 as a marker ... other high-risk breast cancer patients. "We are pleased ...
(Date:5/25/2016)... 2016 According to market research ... and Demand Forecast to 2022 - Industry Insights by ... published by P&S Market Research, the global insulin delivery ... and it is expected to grow at a CAGR ... pump segment is expected to witness the fastest growth ...
(Date:5/25/2016)... Texas , May 25, 2016 ... the issuance to it by the US Patent ... The company,s technology includes proprietary processes for electronic ... for health and wellness programs, HIPAA compliance and ... "Our technology ...
Breaking Medicine Technology: