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:10/12/2017)... (PRWEB) , ... October 12, ... ... ) has launched Rosalind™, the first-ever genomics analysis platform specifically designed for ... complexity. Named in honor of pioneering researcher Rosalind Franklin, who made a ...
(Date:10/11/2017)... ... 2017 , ... Personal eye wash is a basic first aid supply for any work environment, ... eye do you rinse first if a dangerous substance enters both eyes? It’s one less ... with its unique dual eye piece. , “Whether its dirt and debris, or an acid ...
(Date:10/11/2017)...  VMS BioMarketing, a leading provider of patient support solutions, ... Educator (CNE) network, which will launch this week. The VMS ... care professionals to enhance the patient care experience by delivering ... health care professionals to help women who have been diagnosed ... ...
(Date:10/11/2017)... ... October 11, 2017 , ... A new study published ... frozen and fresh in vitro fertilization (IVF) transfer cycles. The multi-center ... success. , After comparing the results from the fresh and frozen transfer cohorts, ...
Breaking Biology Technology:
(Date:8/23/2017)... help is being enlisted in what,s thought to be the biggest study ... body –and are believed to affect health.  ... The Microbiome Immunity Project is the largest study to date of ... goal is to help advance scientific knowledge of the role of these ... The Microbiome ...
(Date:6/23/2017)... ITHACA, N.Y. , June 23, 2017  IBM ... in dairy research, today announced a new collaboration using ... the chances that the global milk supply is impacted ... project, Cornell University has become the newest academic institution ... Chain, a food safety initiative that includes IBM Research, ...
(Date:5/16/2017)...   Bridge Patient Portal , an enterprise ... EMR Systems , an electronic medical record solutions ... established a partnership to build an interface between ... Centricity™ products, including Centricity Practice Solution (CPS), Centricity ... new integrations will allow healthcare delivery networks using ...
Breaking Biology News(10 mins):