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.
Watch this video for more information.
Learn how to meet your ICH E14 regulatory requirements early with EPQT
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
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FAQs
What do health authorities require for cardiac safety assessment in Phase I?
FDA and ICH E14 guidelines require early characterization of a drug’s effects on cardiac repolarization, especially the QTc interval. Typically, this includes intensive ECG monitoring in first-in-human studies and, if needed, a formal TQT study later in development.
Is a standalone TQT study always required?
Not always. If high-quality, concentration-QTc modeling from early-phase ECG and PK data demonstrates no clinically meaningful QT effect, a dedicated TQT study may not be necessary later in development. Regulators accept this “ICH E14 alternative” or “QT Waiver” if the data are sufficiently robust. Clario’s expert team can advise on a QT strategy based on the unique attributes of an individual development program.
Which ECG endpoints are most important?
The primary endpoint in phase I QT analysis is change in the QTc interval from baseline. Secondary endpoints often include change in HR, PR interval, QRS duration and treatment-emergent ECG morphology changes.
What ECG technology should be used in Phase I and Healthy Volunteer trials?
Continuous, digital 12-lead ECG collection with central over-read by a validated ECG core lab has become very standard in early phase and healthy volunteer trials. Leveraging a high-precision measurement methodology for ECG data is also essential, enabling the accurate characterization or exclusion of a drug-related effect on QTc.
Clario has supported 3,600+ early phase cardiac studies.
Let us support your next cardiac study.