Navigation Links
Top 15 Pharmaceutical Company Awards Cardiac Safety Study to iCardiac
Date:9/16/2009

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.

###

Read the full story at http://www.prweb.com/releases/most/automated_QT_studies/prweb2833294.htm.


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

Related biology technology :

1. Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial Evaluating Picoplatin in Small Cell Lung Cancer Reaches 320th Event Target
2. NexGenix Pharmaceuticals to Present at Two Industry Conferences: Rodman & Renshaw 11th Annual Healthcare Conference and Life Sciences Summit 2009
3. ISTA Pharmaceuticals to Present at NewsMakers in the Biotech Industry Conference
4. Access Pharmaceuticals Provides Update on ProLindac(TM)Clinical Development Plan
5. Mpex Pharmaceuticals Announces Positive Phase 2b Clinical Trial Results with Aeroquin(R) (MP-376) Treatment in Cystic Fibrosis Patients
6. Esperance Pharmaceuticals Announces Initiation of Clinical Studies of its Novel Membrane-disrupting Agent, EP-100, in Patients with Cancer
7. Rib-X Pharmaceuticals to Present at the 49th ICAAC
8. Cadence Pharmaceuticals to Present at Two Investment Conferences During the Month of September 2009
9. Dont Wait to Innovate: Future Pharmaceuticals Magazine Releases Its Issue on Innovation in IT, Cell-Based Therapy and Supply Chains
10. EnVivo Pharmaceuticals Names Stephen DiPalma Chief Financial Officer
11. Oramed Pharmaceuticals Commences Human Clinical Trials of an Oral GLP-1 Analog
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... 5, 2016 On Thursday, February 11, ... for community, health and disaster services, and the ... to enhance care coordination and service delivery for the ... need and to better connect service providers to the ... San Diego has handled more than ...
(Date:2/5/2016)... , Feb. 5, 2016 Australian-US drug discovery and ... today the appointment of a new Chairman, Mr John ... , effective immediately. James Garner , has ... Director and former Acting CEO, Mr Iain Ross , ... Director. --> James Garner , has also been ...
(Date:2/4/2016)... -- - New FDA action date of July ... date of July 22, 2016   --> ... 2016   - Lifitegrast has the potential ... the treatment of signs and symptoms of dry eye disease in ... be the only product approved in the U.S. in the past decade indicated for the ...
(Date:2/4/2016)... ... February 04, 2016 , ... Shimadzu ... quad LC-MS, host live demos and poster sessions, and present on the analysis ... conference takes place March 6 to 10 at the Georgia World Congress Center ...
Breaking Biology Technology:
(Date:2/1/2016)... Fla. , Feb. 1, 2016  Wocket® smart wallet ( www.wocketwallet.com ... and television personality, Joey Fatone . Las Vegas ... greet fans. --> Las Vegas , where ... --> The new video ad was filmed at the Consumer ... appeared at the Wocket booth to meet and greet fans. ...
(Date:1/27/2016)... 2016  Rite Track, Inc. a leading semiconductor equipment ... Chester, Ohio announced today the acquisition of PLUS ... in Austin, Texas , will significantly ... modifications, installations and technical support offerings for TEL Track ... commented, "PLUS has provided world class service including refurbishment, ...
(Date:1/25/2016)... , Jan. 25, 2016  Glencoe Software, the ... pharma and publication industries, will provide the data management ... Centre (NPSC). ... Phenotypic analysis measures ... whole organisms, allowing comparisons between states such as health ...
Breaking Biology News(10 mins):