PHILADELPHIA, Sept. 3 /PRNewswire-FirstCall/ -- ERT (Nasdaq: ERES) 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to be the primary reason for drugs being refused licenses or to carry restricted labeling and in the worst cases withdrawn from market completely.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. 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 co
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