eResearchTechnology and Site Support Institute Co., Ltd. Sign Agreement to Deliver Cardiac Safety Services to Japanese Clinical
24 June 2005 - 12:05AM
PR Newswire (US)
eResearchTechnology and Site Support Institute Co., Ltd. Sign
Agreement to Deliver Cardiac Safety Services to Japanese Clinical
Trial Market Leading Japanese Site Management Organization Enters
Digital Cardiac Safety Monitoring Sales Partnership Agreement with
eRT PHILADELPHIA, June 23 /PRNewswire-FirstCall/ --
eResearchTechnology, Inc. (eRT) (NASDAQ:ERES), a leading provider
of centralized electrocardiographic (ECG) collection and
interpretation services, announced today an agreement with Site
Support Institute Co., Ltd. (SSI) (TSE:2386), a leading provider of
site management support services to the Japanese pharmaceutical and
biotechnology industries. This alliance, the first for eRT in
Japan, facilitates the sales activities and in-country support of
Japanese sponsors that require testing of new drug candidates in
conjunction with emerging international cardiac safety regulatory
guidance and technical standards. Under the agreement, SSI will
perform direct selling activities of eRT products and services to
Japanese sponsors, while eRT will perform digital collection,
measurement, interpretation, review and distribution of cardiac
safety data through its EXPeRT(R) workflow-enabled data handling
technology. The eRT technology is the first solution designed
explicitly to meet emerging international guidance and standards
related to cardiac safety monitoring services. eRT supports
clinical trials globally from its network of three core lab
facilities. "Site Support Institute is one of the leading SMOs in
Japan and has significant experience in clinical trial
coordination, including administrative management and GCP-compliant
practical execution," said Robert Brown, senior vice president of
outsourcing partnerships for eRT. "Our sales partnership presents a
great opportunity for eRT to expand its sales presence in Japan
through a professional organization with established Japanese
clinical research relationships. We have observed heightened
awareness and interest in Japan related to cardiac safety
monitoring in all phases of clinical development. This coincides
with the ICH E14 cardiac safety monitoring guidance, which was
recently ratified for implementation. We are pleased to be
announcing the SSI agreement and look forward to working closely
with the SSI team to ensure effective execution of our sales
strategy, which targets cardiac safety services for products in all
phases of development and, specifically, Thorough QT/QTc studies."
"Offering cardiac safety services from eRT, the ECG core lab global
industry leader, will enable SSI to assist sponsors in meeting the
needs of international and regional drug development organizations
conducting trials in Japan," said Ichiro Oshiba, Chief Executive
Officer of SSI. "SSI is the leading provider in Japan of site
management services that are intended to improve the quality of
clinical trials and accelerate pharmaceutical product development.
The partnership between SSI and eRT represents another opportunity
for SSI to serve our clients in their need for comprehensive
cardiac safety testing, including Thorough QT/QTc studies,
especially since regulations are now requiring such studies to be
conducted on a larger scale. We look forward to expanding our
relationship with eRT under the current agreement and believe the
cultures of both organizations will be most complementary." In
concert with another eRT partner, Pharma Bio-Research Group (The
Netherlands), eRT and SSI are sponsoring a seminar in Tokyo on July
7 to provide up-to-the-minute insight into the development of ICH
standards and practical implications for implementation of Thorough
QT/QTc studies and overall cardiac safety programs. The
distinguished panel of experts includes: Dr. Rashmi Shah,
consultant and former senior clinical assessor and author of the
1997 CPMP "Points to Consider" guidance on the same topic; Dr. Joel
Morganroth, eRT chairman and chief scientist; Dr. J.M. de Voogd,
senior clinical research director, Solvay Pharmaceuticals;
Yoshihiro Kuroki, Phase I study operations manager, Bayer Yakuhin,
Ltd.; Dr. Willem Jan Drijfhout, chief scientific officer, Pharma
Bio-Research Group BV; and Dr. Keiji Ueda, senior consultant and
topic leader on ICH E14, Japan PMDA. More than 120 pharmaceutical
professionals are pre-registered for this event. Based in
Philadelphia, PA, eResearchTechnology, Inc. (http://www.ert.com/)
is a provider of technology and services to the pharmaceutical,
biotechnology and medical device industries on a global basis. eRT
is a market leader in providing centralized core-diagnostic
electrocardiographic (ECG) technology and services to evaluate
cardiac safety in clinical development. eRT is also a leader in
providing technology and services to streamline the clinical trials
process by enabling its customers to automate the collection,
analysis, and distribution of clinical data in all phases of
clinical development. Statements included in this release may
constitute forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements
involve a number of risks and uncertainties such as competitive
factors, technological development, market demand, and eRT's
ability to obtain new contracts and accurately estimate net
revenues due to variability in size, scope and duration of
projects, and internal issues in the sponsoring client. As a
result, actual results may differ materially from any financial
outlooks stated herein. Further information on potential factors
that could affect eRT's financial results can be found in eRT's
Reports on Forms 10-K and 10-Q filed with the Securities and
Exchange Commission. DATASOURCE: eResearchTechnology, Inc. CONTACT:
Joan Sterlacci of eResearchTechnology, Inc., +1-908-203-6473; or
Matt Hayden, Hayden Communications, +1-858-704-5065, for eRT Web
site: http://www.ert.com/
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