ERT celebrates a significant milestone: Completes 150Th QT clinical Trial

NewsGuard 100/100 Score

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to be the primary reason for drugs being refused licenses or to carry restricted labeling and in the worst cases withdrawn from market completely.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 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.

Source: http://www.ert.com

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Can psychedelics improve sexual functioning and satisfaction?