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Phase I/TQT Cardiac Assessment

Fulfill your ICH E14 requirement early, minimize risk and potentially reduce costs throughout your trial by collaborating with our Phase 1 Center of Excellence.

Every millisecond of precision counts when assessing cardiac safety.

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Overview

Receive precise and cost-effective QT assessments with Early Precision QT (EPQT). Quality QT/QTc data is imperative in today’s competitive R&D market. Clario supported 70% of all new drug approvals from 2019-2020 offering a full range of support — from study design through submission — for formal Thorough QT studies and for assessing QT safety in clinical trials for which a traditional TQT study is not feasible.

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Learn how to meet your ICH E14 regulatory requirements early with EPQT

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Product detail

Confidently implement EPQT in your Phase 1 studies to enable earlier, more precise and cost-effective cardiac safety assessments and potentially qualify for a TQT waiver. The EPQT methodology was clinically proven in a comprehensive clinical trial, which concluded that ECGs collected and analyzed during routine early-phase studies could reliably provide cardiac safety information typically derived from dedicated TQT studies.

Understand QT and other ECG effects of a new drug and ensure compliance with ICH E14 Regulation
Obtain reliable, precise data earlier in development using clinically proven proprietary Early Precision QT methodology
Navigate unexpected issues throughout your trial by collaborating with our Phase 1 Center of Excellence
Partner with Clario Certified Sites who are well-trained and well-equipped to shorten study startup times and collect quality data
Ensure promising drugs and therapies aren’t eliminated due to inaccurate data