October 06, 2005
First Mover Advantage Ensures Digital ECGs Provided by eRT to Sponsors Will Meet Technical Requirements for Use of Mortara’s E-Scribe Digital Warehouse Services And Address Mandate for All Digital ECGs Submitted to the FDA
PHILADELPHIA, PA October 6, 2005/PR Newswire/--eResearchTechnology, Inc. (eRT), (NASDAQ: ERES), a leading provider of centralized electrocardiographic (ECG) collection and interpretation services, announced today that it is the first ECG core laboratory to successfully complete the XML Certification Process under the Mortara Certified Partner program.
The certification ensures that annotated digital ECGs provided by eRT to sponsors will be compatible with the HL7 annotated ECG standard required for loading into the E-Scribe ECG Warehouse. The E-Scribe ECG Warehouse, developed by Mortara under a Cooperative Research and Development Agreement (CRADA) with the U.S. Food and Drug Administration (FDA), is intended to facilitate FDA review and warehousing of annotated ECG datasets. In July, eRT was designated by Mortara as the exclusive ECG core laboratory reseller of E-Scribe ECG Warehouse Services, enabling eRT to offer drug developers full lifecycle solutions for sponsors to view and manage large volumes of digital ECGs and review waveforms for significant outliers using the same toolset and environment Mortara has implemented for use by the FDA.
“We are delighted at having successfully leveraged our technology expertise and close partnership with Mortara to bring this important first mover advantage to sponsors contracting with eRT for cardiac safety services for drug development programs,” said Scott Grisanti, senior vice president of business development and chief marketing officer at eRT. “We expect all Thorough QT studies and other critical studies so designated by regulators that are submitted to the FDA from this point forward will need to adhere to the HL7 annotated ECG standard regardless of when those studies were conducted. This makes mastery of the XML standard a new mission critical core competency for ECG core laboratories. We look forward to setting the standard for service excellence in this important new area and to complementing our technical deliverable with our exclusive ability to provide sponsors access to E-Scribe ECG Warehouse Services so that they might take full advantage of the solution’s sophisticated analytical capabilities designed to advance cardiac safety in new drug development.”
Justin Mortara, vice president of Mortara Instrument commented, “We are very pleased to announce eRT as the first Mortara Certified Partner. Collaborating closely together we have been able to ensure compatibility of eRT annotated waveform data with the HL7 standard required by the E-Scribe ECG Warehouse. This important step means that data from eRT analyzed studies can be smoothly uploaded to the E-Scribe ECG Warehouse, without being flagged and consequently blocked by the import validation process. As an important strategic partner, and the exclusive central laboratory reseller of the E-Scribe ECG Warehouse Services, it was important to leverage our strategic partnership and achieve early Certified Partner status for eRT. We look forward to providing our HL7 expertise under the Mortara Certified Partner program to others in industry and likewise assist them in meeting the detailed requirements of the HL7 standard.”
Based in Philadelphia, PA, eResearchTechnology, Inc. (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.
Based in Milwaukee, WI, Mortara Instrument, Inc. is distinguished in the field of non-invasive cardiology for innovations that are the core of the company’s complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company’s website is www.mortara.com.
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.