iCardiac’s services meet all the regulatory, logistical and scientific requirements of today’s cardiac safety studies. At the same time, next generation services enable sponsors to overcome the limitations of current practices. iCardiac has developed solutions to address the unacceptable level of QTc false-positives and false-negatives in drugs that affect heart rate and autonomic tone and the excessive expense associated with conventional cardiac safety studies.

Integrated Study Design

The iCardiac team considers unique aspects of the drug program in its study design while rigorously adhering to regulatory and industry standards. The iCardiac team reviews relevant non-clinical and clinical data to develop the most robust strategy for each drug while utilizing cost-efficient study design. A multidisciplinary team of leading CV safety experts with deep experience in Cardiology, Electrophysiology, Long QT Syndrome, ECG Signal Evaluation, Pharmacology, Toxicology and Regulatory Affairs is available for consultation on study design or the development of the full study protocol.

COMPAS Platform: Maximizing Precision and Avoiding False Positives

iCardiac has pioneered several advanced Holter-based solutions that dramatically reduce false-positive and false-negative results in drugs affecting autonomic tone, an approach that cannot be duplicated with conventional QTc assessment methods. COMPAS technology platform offers Highly Automated, QTbtb, Restitution and Beyond QT solutions that enable sponsors to improve the precision of QT analysis, identify benign effects that frequently lead to false positive interpretations, and gain deeper insight into the relative arrhythmia liability for those compounds that may prolong QT interval but have an outstanding therapeutic profile. These tools also increase the precision of ECG measurements and allow for a reduction of the sample size needed to power a QT study.

Early CV Safety Assessment

iCardiac’s advanced solutions enable reliable characterization of QT effects with high precision within Phase I SAD/MAD studies. This unique service provides “de-risking” of the important drug candidates in early development. As a result, drug developers can design later stage TQT studies with confidence and in some cases (e.g., Oncology) satisfy regulatory requirements without conducting a dedicated QT study. This unique solution reduces the total cost of CV safety assessment and reduces the risk of late-stage attrition due to CV safety issues not recognized in conventional clinical studies.

Study Sample-Size Reduction

iCardiac’s analytical solutions are designed specifically for drug development purposes, where precision and power requirements are far greater than those typically utilized in diagnostic clinical settings. Our highly automated approach carefully and reliably identifies the data that requires manual adjudication by trained technicians and cardiologists, while leveraging precision and computing power of the software algorithms. As a result, iCardiac’s ECG analyses have significantly higher precision than conventional analysis methods do. The increased precision of ECG measurements allows for substantial reduction in the sample size required for a given level of power in a TQT study. The sponsor may decide to reduce the study size and cost, or gain significantly more precise measurements with a traditional TQT study size. iCardiac analytics are fully ICH E 14 compliant and have been successfully used in FDA data submissions and drug approvals. iCardiac’s proprietary QTbtb analysis can provide high-precision evaluation of the QT interval effects in very small sample sizes, making it an ideal go/no-go analysis tool for application within conventional SAD/MAD studies.