Benefits of iCardiac Services:

Reduce the likelihood of a false positive or an over-estimated QT prolongation in Thorough QT studies, a possible problem in up to 25% of studies conducted by            most traditional ECG core laboratories.

Accurately assess drugs that affect heart rate, which is a challenging QT problem for CNS, GI and many other types of drugs.

Use ICH E14 compliant automated QT analysis to improve robustness of results and reduce study cost by up to 50%

Rigorously characterize the safety profile of new HERG-blocking agents by quantitative comparison with known HERG-blockers (moxifloxacin, sotalol).

Expert report preparation by a scientific/medical team that serves as cardiac safety advisers to leading pharmaceutical companies and the FDA.

Ensure that your cardiac safety study is completed on time and on budget.

Advanced QT Analysis Tools
iCardiac’s industry leading ECG core laboratory leverages the COMPAS suite of tools to maximize the precision and decrease the cost of cardiac safety assessment from First-in-Human studies to Phase III studies including following the FDA’s E14 QT/QTc guidance for Through QT Studies (TQT). This suite of tools was originally developed and validated at both the University of Rochester’s World Leading Heart Research Follow Up Program (HRFUP) as well as in Pfizer’s Research and Development programs. Since its development, the COMPAS platform has been used for over a decade in support of clinical trials.

• Thorough QT Plus minimizes the effect of heart rate changes by selecting the optimal ECG periods for measurement resulting in increased QT precision. • FDA-accepted Highly Automated QT increases analysis robustness, reduces analysis time and increases the amount of data that can be analyzed per subject while reducing cost by eliminating the need for cardiologists to manually review all ECG data. • Dynamic QTbtb Analysis significantly improves the precision of the QT measurement and reduces the likelihood of false positives. It also dramatically reduces the number of subjects required for a study.

Advanced Biomarkers
Electrocardiographic markers that provide a complement to the (ICH E14) QT interval prolongation marker and deliver more definite results.

•Focused on repolarization morphology and dynamics that characterize a drug’s effect on specific ion channels in the heart. •Proven to be a more reliable measure than QT prolongation in validation studies with top pharmaceutical companies and academic institutions. •Can be applied from preclinical to phase IV clinical trials.

“Best practice recommendations on utilizing advanced
ECG Biomarkers in cardiac safety assessment of drugs
in development”

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