NewswireToday - /newswire/ -
Philadelphia, PA, United States, 2009/09/04 - ERT, a leading provider of centralized ECG, ePRO and other services to the biopharmaceutical, medical device and related industries has celebrated a significant milestone by completing its 150th Thorough QT clinical trial (TET).
ERT provides full TET support to the biopharmaceutical industry, including consultation, study design and provision of ECG equipment to ECG analysis, data processing, management, reconciliation, reporting, quality control and regulatory support.
Cardiac safety concerns continue to be the primary reason for drugs being refused licenses or to carry restricted labeling and in the worst cases withdrawn from market completely. As a result, all new drugs are expected to undergo electrocardiographic testing (ECG) in the clinical development process and with the advent of the ICH E14 Guidance, a TET study is required for most drugs where more robust and rigorous ECG testing is performed. A TET study, unlike a typical Phase I clinical trial, costs in the region of $1.5 million to $2.5 million, highlighting the importance placed on these studies. It is estimated that a total of 300 TET studies have been carried out worldwide since the introduction of the guidance in 2005, which places ERT as the leader of TET expertise in the industry after completing its 150th study.
John Blakeley, Executive Vice President of ERT, said, “The TET study plays a crucial role in the development of a new pharmaceutical product. We are very excited to have supported the industry to help improve the cardiac safety of new drugs coming to market. We would like to take this opportunity to thank our partners and customers for placing their trust in us, and we look forward to continuing to build on this in the future. At ERT we only have one focus, which is the delivery of accurate and reliable results to our customers.”
ERT’s proven cardiac safety solutions offer a centralized process for the collection and analysis of quality ECG data. Its centralized core lab provides real-time collection of consistent, quality ECG data ― a critical element in the accurate assessment of a new drug’s cardiac effect. Centralization not only reduces inconsistencies that may occur from site to site, but also alleviates clients’ workloads. ERT simplifies ECG data management and analysis to provide on-demand, real-time access to ECG study data.
For further information on ERT and its technology and services please email info[.]ERT.com, call +1 215 972 0420.
About eResearchTechnology, Inc. (ERT)
Based in Philadelphia, PA, ERT (ert.com) is a leading provider of centralized ECG, ePRO, and other services to the biopharmaceutical, medical device, and related industries. ERT products and services are enabled by EXPERT®, the Company’s robust, secure, and validated clinical research workflow-processing system that powers centralized electronic data collection, data management, and information exchange.
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, which could cause actual results to differ materially from those expressed or implied from such statements. These risks and uncertainties include, without limitation, the Company's ability to obtain new contracts, variability in size, scope and duration of projects, integration of acquisitions, competitive factors, technological development, market demand, and other factors described in the Company's filings 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.