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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/