PRACS Institute, Ltd. Selects eResearchTechnology to Provide Integrated Suite of Software and Services
January 04 2005 - 9:05AM
PR Newswire (US)
PRACS Institute, Ltd. Selects eResearchTechnology to Provide
Integrated Suite of Software and Services Agreement Includes
Enterprise Electronic Data Capture, Data Management, and Web Portal
Solutions for Deployment Across All Phases of Clinical Development
PHILADELPHIA and FARGO, N.D., Jan. 4 /PRNewswire-FirstCall/ --
eResearchTechnology, Inc. (eRT) (NASDAQ:ERES), a leading e-research
technology and services provider, announced today that it has
entered into an agreement to provide PRACS Institute, Ltd., North
America's largest privately held contract research organization
focusing on Phase I-related services, with an integrated technology
and services solution that includes enterprise electronic data
capture (EDC), clinical data management, and a web portal for
client access to real-time data. Financial terms of the agreement
were not disclosed. PRACS will deploy eRT's Enterprise EDC
platform, which includes the eResearch Community portal and eData
Management clinical data management application for collecting and
cleaning electronic and paper-based clinical trial information. The
solution will support development of harmonized processes across
all phases of clinical development for rapidly growing PRACS,
which, in addition to its Fargo headquarters, includes operations
in East Grand Forks, Minnesota, and San Diego, California. eRT's
Enterprise EDC platform will be implemented to support PRACS'
ability to provide sponsors with an EDC solution that can scale
from a single trial to an entire development program. Also, PRACS
will deploy eRT's eResearch Community web portal for overall
command and control, real-time analysis and decision support, and
collaboration and communications across its clinical research
network. In addition to technology licenses and maintenance, the
agreement leverages eRT's full range of services, including: --
Regulatory compliant hosting -- Configuration and implementation of
initial EDC studies -- eHealth Education web-based training --
Packaged kits and associated services to support effective
development of standard operating procedures In July 2003, the
companies announced a non-exclusive alliance for providing
integrated solutions for Thorough QT studies, which monitor cardiac
safety and a drug's impact on the QT interval. Under the agreement,
PRACS conducts clinical trials at 17 Phase I units at its
headquarters in Fargo and facility in East Grand Forks, while eRT
performs digital collection, measurement, interpretation, review
and distribution of cardiac safety data through its EXPeRT(R)
workflow-enabled data handling technology. "We are pleased at being
given the opportunity to deepen our partnership with PRACS by
providing an infrastructure for enterprise EDC and clinical data
management that will scale to support PRACS' continued growth and
expansion across all phases of clinical development," said Scott
Grisanti, senior vice president of business development and chief
marketing officer at eRT. "In addition, the eResearch Community
tool will provide a backbone for collaboration across PRACS
facilities, investigative sites, and sponsors. eRT is unique in its
ability to deliver partners both end-to-end solutions for
automating key clinical research processes and leading ECG central
laboratory services to meet the needs of today's demanding Thorough
QT studies, along with routine Phase I and later phase cardiac
safety services." Dr. James Carlson, founder and president of PRACS
Institute, Ltd., commented, "Implementation of an EDC solution that
can support our expanding business across all phases of development
will extend and enhance the services we can offer to sponsors. We
have enjoyed a terrific partnership with eRT in the area of cardiac
safety services, especially in the Thorough QT study area. We look
forward to delivering even more value to the drug development
industry by leveraging eRT's technology and services, which will
allow us to collaborate closely with our clients in conduct of
studies across a wide range of therapeutic areas and specialties."
About PRACS Institute, Ltd. Based in Fargo, North Dakota, PRACS
Institute, Ltd. (http://www.pracs.com/), has served the innovator
and generic pharmaceutical industries for over 20 years with
full-service on-site clinical and bioanalytical capabilities for
Phase I-IV studies. PRACS Institute offers the highest quality
contract research and related services with state-of-the-art
clinical and bioanalytical facilities comprising 17 study units and
540 beds, a large, highly-compliant healthy subject population,
experienced staff, Sciex and Micromass mass spectrometry,
bioanalytical sample analysis and an excellent FDA audit record. In
addition, with the 2004 acquisition of the clinical research
divisions of DermTech International, PRACS has incorporated
renowned dermatology/consumer product testing expertise, including
pre- clinical in vitro Franz diffusion cell, and in vivo
dermatopharmacokinetic capabilities, along with full-service
management of Phase I-IV clinical dermatology trials. About
eResearchTechnology (eRT) 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. The company is a
market leader in providing centralized core-diagnostic
electrocardiographic (ECG) technology and services to evaluate
cardiac safety in clinical development. The company 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 the
company'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 the company's financial results can be found in
the company's Reports on Forms 10-K and 10-Q filed with the
Securities and Exchange Commission. DATASOURCE:
eResearchTechnology, Inc. CONTACT: Joan Sterlacci,
eResearchTechnology, Inc., +1-908-203-6473, or Matt Hayden, Hayden
Communications, +1-858-456-4533, for eResearchTechnology Web site:
http://www.pracs.com/ Web site: http://www.ert.com/
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