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,
|SOURCE eResearchTechnology, Inc.|
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