|Emerging North American Pharmaceutical Company Awards $1 Million Study to eResearchTechnology for Cardiac Safety Monitoring and Information Distribution Services|
Tuesday November 2, 9:05 am ET
Award Leverages New eRT Semi-Automated Service Offering
PHILADELPHIA, Nov. 2 /PRNewswire-FirstCall/ -- eResearchTechnology, Inc. (eRT), (Nasdaq: ERES - News), a leading provider of centralized electrocardiographic (ECG) collection and interpretation services, announced today that it has been awarded approximately $1 million in cardiac safety monitoring and services from a growing North American pharmaceutical organization for one of its key drug candidates in later phase clinical trials.
The award covers an extensive Phase II/III study, for which eRT will provide comprehensive support, including provision of 24 units of digital 12- lead ECG equipment designed to facilitate collection of cardiac safety data that is subsequently provided to eRT for analysis. eRT will perform digital collection, measurement, interpretation, review, and distribution of cardiac safety data through its EXPeRT® workflow enabled data handling technology, the first solution in production that was designed explicitly to meet emerging international regulatory guidance and technical standards.
The solution for the studies will include eRT's latest "semi-automated" service offering, which features the ability to leverage cardiac safety measurements calculated by ECG collection equipment that are later verified by full cardiologist review and adjudication. The new service is positioned for routine later phase studies on compounds that, in the assessment of the drug development sponsor, have a negative or "clean" cardiac safety signal. It is consistent with the latest published regulatory guidance, which affords sponsors latitude in selecting the measurement methodology for a particular trial based on the level of precision needed. This offering includes the same eRT unmatched cardiology resources, Project Assurance services, data handling, and Digital ECG Community portal and eReporting Bulletin Board solutions that distinguish eRT's traditional service, which is based on manual calculations of all cardiac safety measurements.
"We are pleased with this award, which is important for several reasons," said Scott Grisanti, senior vice president of business development and chief marketing officer at eRT. "First, it marks an agreement of very significant value from a new name account. Second, it signals a broadening acceptance of eRT's latest offering, which was brought to market earlier this year and has been selected by a number of sponsors in a variety of therapeutic areas. This new solution expands the range of cardiac safety services that eRT can offer the new drug development industry."