eRT Completes Milestone 100th Thorough QT Study
October 14 2008 - 11:00AM
PR Newswire (US)
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/.
Forward-looking statements 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. DATASOURCE:
eResearchTechnology, Inc. CONTACT: Keith Schneck, Executive Vice
President and Chief Financial Officer, eResearchTechnology, Inc.,
+1-215-282-5566, Web site: http://www.ert.com/
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