Early Precision QT (EPQT) is a cutting-edge cardiac assessment solution for Phase I clinical trials, offering precise and cost-effective QT assessments. This innovative approach enables earlier, more accurate cardiac safety evaluations, potentially qualifying for a TQT waiver. EPQT has been clinically proven to provide reliable cardiac safety information typically derived from dedicated TQT studies. It ensures compliance with ICH E14 Regulation while offering a comprehensive range of support from study design to submission. Clario, the provider of EPQT, has supported 70% of all new drug app...
Vendor
Clario
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Early Precision QT (EPQT) is an advanced cardiac assessment solution designed for Phase I clinical trials. It offers precise and cost-effective QT assessments, enabling researchers to conduct earlier and more accurate cardiac safety evaluations. This innovative approach has been clinically proven to provide reliable cardiac safety information typically obtained from dedicated Thorough QT (TQT) studies. EPQT is particularly valuable in today's competitive R&D market, where quality QT/QTc data is crucial. The solution ensures compliance with ICH E14 Regulation and offers a comprehensive range of support, from study design through submission, for both formal TQT studies and QT safety assessments in clinical trials where traditional TQT studies are not feasible.
Key Features
Early and Precise Cardiac Safety Assessment EPQT enables earlier, more precise, and cost-effective cardiac safety assessments in Phase 1 studies.
- Potential qualification for a TQT waiver
- Clinically proven methodology for reliable cardiac safety information
Comprehensive Support Clario offers full-range support throughout the clinical trial process.
- Assistance from study design to submission
- Collaboration with Phase 1 Center of Excellence for navigating unexpected issues
Regulatory Compliance EPQT ensures adherence to important regulations in drug development.
- Compliance with ICH E14 Regulation
- Understanding of QT and other ECG effects of new drugs
Benefits
Cost-Effective and Time-Efficient EPQT optimizes the cardiac assessment process in clinical trials.
- Earlier obtainment of reliable, precise data in drug development
- Shortened study startup times through partnership with Clario Certified Sites
Enhanced Drug Development Process The solution contributes to a more effective and accurate drug development journey.
- Prevention of promising drugs being eliminated due to inaccurate data
- Improved understanding of cardiac safety earlier in the development process
Expert Support and Collaboration Users benefit from Clario's extensive experience and partnerships.
- Access to industry key opinion leaders for regulatory consultation
- Collaboration with well-trained and well-equipped Clario Certified Sites