eResearchTechnology, Inc. Clinical Research
 



Tuesday April 22, 12:32 pm ET


Press Release

SOURCE: eResearchTechnology, Inc.

eRT Among First To Receive CDISC Certification for New Standard

EXPeRT(R) Data Capture product compliant with industry Operational Data Model

PHILADELPHIA, April 22/PRNewswire-FirstCall/ -- eResearchTechnology, Inc. (eRT), (Nasdaq: ERES - News), has received certification from the Clinical Data Interface Standards Consortium (CDISC) for its EXPeRT® Data Capture product, which complies with CDISC's Operational Data Model (ODM), the industry standard for clinical data acquisition and archiving. The ODM standard is gaining increasing recognition as the ideal data transport method across the entire clinical trial enterprise.

EXPeRT® Data Capture is an easy to use, high performance electronic data capture tool. It is an integrated component of eRT's eClinical Suite. EXPeRT® Data Capture is a preconfigured solution, compliant with the U.S. FDA's 21 CFR Part 11 requirements, that significantly accelerates the deployment and implementation of electronic data capture while reducing overall cost. eRT is among the first to introduce an ODM-compliant product, with EXPeRT® Data Capture enabling information system interoperability in clinical trials.

"eRT is a strong proponent of standards to assist the transport and processing of digital clinical data to improve medical research," says Dr. Michael McKelvey, president and CEO. "eRT was the first adopter of Health Level Seven's electrocardiogram standard, an early adopter of the E2B European standard for adverse event reporting, and now we have a certified product compliant with CDISC's ODM standard."

EXPeRT® Data Capture now includes built-in standardized metadata that complies with the ODM standard, giving eRT a competitive advantage and the ability to offer clients industry-leading capabilities. "To meet our clients' clinical research needs, we continue to improve our platform for electronic data capture. Our special EDC Now! program combines eRT's product and services strategy to further enable the rapid design and implementation of standards- based EDC studies," says Mr. David Laky, vice president and general manager of the Clinical Applications Group.

About eResearchTechnology, Inc.

Philadelphia-based eResearchTechnology (www.eRT.com) delivers technology- based products and services that enable pharmaceutical, biotechnological and medical device companies to collect, interpret and distribute cardiac safety and clinical data more efficiently. eRT is a market leader in centralized electrocardiographic (ECG) services-a core diagnostic capability-and a leading provider of technology and services that allow customers to automate and streamline data-based components of clinical trials, helping them bring new drugs to market faster.

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.


SOURCE: eResearchTechnology, Inc.


back to main page