 |
Cetero Research Announces CorWatch, a Cardiac Safety Suite of Services
Cary, NC (March 13, 2007 ) —Cetero Research, a leading clinical contract research organization (CRO), announced its enhanced focus on conducting cardiac safety assessments through CorWatch, an integrated suite of services tailored to cardiac safety trials in any phase of development.
CorWatch is a comprehensive, cardiac safety suite of services combining significant clinical pharmacology expertise, strategic relationships with key core ECG laboratories, data management, study design consultation and program development.
As a pioneer in providing accurate QTc data, Cetero Research has conducted more than 20 definitive trials and successfully recruited more than 2,000 participants in the last two years"more than any other CRO in the world.
"QTc assessments are critical to drug development programs. Whether the cardiac safety assessments are integrated into a Phase I trial in order that clients have the ability to make critical decisions early or are incorporated into later phases to provide the definitive data necessary to file a New Drug Application (NDA), we have an impeccable foundation of expertise," stated Alan Copa, President of PRACS Institute, LTD, a founding company of Cetero Research. "The key is to be able to conduct a trial in one place, with the least number of groups. Because Cetero has the largest bed capacity of any CRO and the most experience conducting QTc trials, we understand the nuances."
The required identification of any QT/QTc interval prolongation and proarrhythmic potential for new non-antiarrhythmic drugs is based on the Food and Drug Administration’s ICH E14 industry guidance. Since the guideline’s inception, there has been continued focus on the effect new drugs have on cardiac repolarization. The need for a thorough, well-designed and effectively executed QTc trial with statistical significance lies at the heart of submitting an NDA.
"Cetero is focusing on cardiac safety assessments based on how crucial they are to our clients. We have formed strategic partnerships with core ECG laboratories and equipped our facilities with state-of-the-art equipment and experienced staff," said John Capicchioni, Cetero Research’s Vice President of Business Development. "We truly consider CorWatch to be the leading suite of services for cardiac safety assessments."
Cetero offers the full spectrum of clinical research services to meet the needs of the pharmaceutical and biotechnology industries. Cetero’s clinical research capabilities and expertise are unparalleled in the clinical research industry with more than 1,400 beds, including 120 dedicated hospital beds, and a foundation of over 5,000 trials. The company also specializes in bioanalytical services, utilizing over 600 available assays and providing method development and validation along with sample analysis via LC/MS/MS and HPLC.
Cetero, the leading provider of early clinical and bioanalytical services, is the union of PRACS Institute, Ltd., Gateway Medical Research and Ba Research International.
Cetero Research’s corporate headquarters are located in Cary, NC.
For more information about Cetero Research please contact:
John L. Capicchioni, Vice President, Business Development
Tel: 201-818-9346, info@Cetero.com or visit our website @ www.cetero.com
|
