Critical step in determining cardiac safety of new drugs
PHILADELPHIA, Oct. 14 /PRNewswire-FirstCall/ -- eResearchTechnology, Inc. (eRT), announced today the completion of its 100th Thorough QT Study. QT has been identified as a crucial cardiac safety marker; specifically, the prolongation of QTc is a known surrogate for assessing the cardiac safety risk of a new drug. eRT conducts Thorough QT Studies as one of the centralized ECG services provided within its EXPeRT platform for Cardiac Safety.
According to the most recent regulatory guidance, from the FDA and the ICH E14 Step 5 adopted in October 2005, the development of most candidate drugs should include a QT study conducted with standardized and validated digital equipment, designated cardiologists, consistent measurement methodology and digital data collection, storage and submission in XML format.
eRT began performing Thorough QT/QTc E14 trials as early as 2002. "Since then, the pharma industry has grown to understand the necessity of this type of study to preserve cardiac safety and mitigate the repolarization effects of new drugs," said Jeffrey Litwin, M.D., and Chief Medical Officer. "We have now completed 100 such trials, working with sponsors of all sizes, to construct and conduct these studies in a scientifically valid manner, providing the scientific and operational expertise they need for this important aspect of drug development."
Dr. Michael McKelvey, president and chief executive officer, commented, "The Thorough QT Study often stands as the gateway to Phase III studies and has become a known and accepted part of the drug development process. Coupling our TQT expertise with our breadth and depth in the Phase III environment allows us to continue driving value for our sponsors, helping them reach final regulatory hurdles with robust, high quality cardiac safety data. It is the lack of this data that remains the most significant barrier to final drug approval, and eRT is proud of our achievement in reaching this important 100 TQT milestone."
The significance of the TQT study in regulatory reviews and patient safety makes the careful selection of a cardiac safety provider all the more important. According to Robert Brown, senior vice president, Strategic Marketing, Planning and Partnerships, "eRT's clients and clinical pharmacology partners benefit greatly from our extensive experience and overall clinical, scientific and regulatory insight. From pre-study consultation through study lock, our cardiologists, project managers and other technical experts work in sync with sponsors and pharmacology partners. And our proven Project Assurance methodology delivers final, credible, regulatory-compliant data and expert reports on time and on budget."
Since the inception of the TQT in 2002, eRT has been at the forefront of providing Thorough QT Study ECG services, including offering strategic partnerships with clinical pharmacology units as well as scientific and regulatory consulting to sponsor organizations.
About eResearchTechnology, Inc.
Philadelphia-based eResearchTechnology (Nasdaq: ERES) delivers technology- based products and services that enable pharmaceutical, biotech and medical device companies to bring new drugs to market faster. Specifically, eRT helps clients to more efficiently collect, interpret and distribute cardiac safety and clinical study data more efficiently. eRT is a market leader in centralized electrocardiographic (ECG) services-a core diagnostic capability- and services for Electronic Data Capture and electronic Patient Reported Outcomes. More information at http://www.eRT.com.
Statements included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including but not limited to 2008 financial guidance, involve a number of risks and uncertainties such as the company's ability to obtain new contracts and accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration of projects, and internal issues at the sponsoring client, integration of acquisitions, competitive factors, technological development, and market demand. As a result, actual results may differ materially from any financial outlooks stated herein. Further information on potential factors that could affect the company's financial results can be found in the company's Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
|SOURCE eResearchTechnology, Inc.|
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