Scientific and Medical Expertise:

iCardiac’s team of scientists, board certified cardiologists, and thought leaders has extensive expertise in the design, conduct, and analysis of world-wide, multi-center, clinical research studies ranging from 100-3,500 subjects. They have been involved in over 150 INDs, and in over 100 clinical studies in cardiovascular patients, Long QT Syndrome patients, and in healthy normal volunteers.

The team’s experience represents all major therapeutic areas including:

Addiction
Anti-bacterials
Atherosclerosis
Cardiovascular
Central Nervous System
Diabetes
Multiple Sclerosis
Oncology
Osteoarthritis
Osteoporosis
Respiratory
Rheumatoid Arthritis
Sexual Health
Vaccines

The team has been involved in basic and clinical research covering arrhythmia liability and cardiac safety and is responsible for a number of industry firsts, including the FDA accepted validation of Highly Automated QT^sm. Additionally, the team has been a pioneer in the field of autonomic nervous system effects on QT interval, which is estimated to produce false-positive results in conventional QT studies for as many as 25% of all molecules currently in clinical development. Several team members are active consultants to the FDA and contributors on several working groups that are advancing the field of cardiac safety.

Study Design:

iCardiac’s prides itself in effective and efficient study design taking into account the specific pharmacology of the compound. A number of molecules may be susceptible to false positives. As a result it is important to consider and select the appropriate analysis methodology to avoid such a risk. In the determination of the study design, iCardiac works closely with the sponsor to understand all the existing pre-clinical and clinical data and makes recommendations in regard to the most reliable and cost effective study design that anticipates regulatory and data issues (if any) that may arise with the study drug and meets all regulatory and quality requirements and objectives.

Data and Project Management:

iCardiac’s data and project management team is run by industry veterans with extensive core laboratory experience. As a result, all processes, procedures and IT systems have been designed to provide maximum reliability and efficiency. Additionally, iCardiac coordinates data collection and equipment deployment to sites ranging from single center Phase I units to multi-center studies. iCardiac’s project management philosophy is focused around proactive communication and close partnership with the sponsors and the sites to assure timely completion of the projects on or ahead of schedule.

ECG Analysis:

iCardiac has the industry’s broadest set of FDA accepted tools for the determination of primary and secondary end-points for QT studies. iCardiac’s core technology platform COMPAS has been used in clinical studies for over a decade. The analysis methodologies range from fully manual ECG analysis by U.S. board certified cardiologists to Highly Automated QT techniques that have been more extensive validated than any other automated approach currently on the market. Additionally, iCardiac offers a range of advanced tools for improving the precision of QT measurements – Thorough QT Plus^sm – as well as tools for reducing the probability of false positives – QTbtb^sm. Finally for those drugs that are know to be HERG positive, iCardiac offers Beyond QT^sm, a set of analytical services aimed at determining the relative risk of a HERG positive compound. All analysis performed by iCardiac are conducted at iCardiac’s centralized core laboratory under the guidance of U.S. board certified cardiologist.

Statistical Reporting:

iCardiac has extensive experience in the design and preparation of both interim and final statistical reports in support of Through QT and other cardiac safety studies. iCardiac works closely with the sponsor to understand the specific study requirements and determines the appropriate statistical analysis approach that meets the objectives and is regulatory compliant.

Data Submission:

iCardiac can support and handle all data submission requirements for FDA ECG Warehouse on behalf of the sponsor. In addition, in their academic capacity, Principals from iCardiac have played a critical role in helping establish the Telemetric and Holter ECG Warehouse, which is a partnership between the University of Rochester and the FDA with the objective of serving as a repository of Holter ECG data and advancing the field of research in advanced tools for ECG analysis in cardiac safety trials.

Interface with the Regulators:

Principals at iCardiac have extensive experience in working the regulators around the development of new ECG analysis methodologies, strategies, as well as study specific protocols. Currently several principals are serving in various advisory roles for the FDA.