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Qualia understands that drug development programs require the identification of QT/QTc prolongation through the conduct of Thorough ECG Trials (TET). The design and implementation of a clinical pharmacology studies plays a critical role in this evaluation process. Our team consults with sponsors to integrate the design of protocols that address issues of cardiovascular safety. Qualia individually designs each study based on the compound’s pharmacodynamic and pharmacokinetic characteristics. We maintain partnerships with leading ECG core labs and we have experienced clinical staff, cardiologists, and principal investigators conducting cardiac safety studies.
U.S. and European regulatory agencies continue to emphasize the inclusion of (ECGs) in clinical trials to ensure patient safety before drugs are cleared for marketing. Accurate and thorough data collection, interpretation and archiving are essential to the success of drug development. To complete your cardiac safety trials, you need an organization you can trust — an organization with the right expertise, experience, systems and technology.
To best meet your needs in Cardiac safety, Qualia has created an ICU-like unit primarily for the conduct of thorough QT/QTc studies under the guidance of E14 promulgated by ICH.
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