iCardiac Certified Partner Program
In December of 2014, an industry-wide meeting was held at the FDA to announce the results of a validation study demonstrating that actionable cardiac safety data can be obtained through intensive ECG collection during certain routine Phase I trials, such as SAD or MAD studies. The validation study utilized the unique Early Precision QT methodology of iCardiac, as well as its project management and analysis personnel. The validation study was indisputably successful, in that all prospectively defined criteria were clearly met. As a result, many sponsors can capture critical information about their compound’s effect on the QT interval as part of their First-in-Human studies. In many instances, sponsors will be able to apply for a Thorough QT (TQT) study waiver from the FDA, saving substantial time and money by eliminating this significant hurdle. Sponsors will also gain critical information earlier, which they can leverage in outside partnering discussions and internal pipeline decisions.
Early Precision QT Assessment Is Only Available Through Certified Partners
iCardiac has now launched Early Precision QT as a comprehensive service that embodies the same design principles and unique ECG analysis methodology used in the validation study. However, sponsors looking to emulate the success of this study need access to high quality, well-trained sites. This led iCardiac to launch its iCardiac Certified Site program. iCardiac Certified Partner Sites have the ability to conduct studies that result in the collection of very high quality ECG data, which is critical in these early QT studies. As noted above, the value to sponsors ranges from millions of dollars saved through a TQT waiver, to much more in economic value delivered when they leverage the information in more effective partnering or prioritization activities earlier in the process.
iCardiac Announces an Industry-First Full Risk-Sharing Program For TQT Studies
There is another advantage to working with an iCardiac Certified Site. If a sponsor needs a Thorough QT study to be completed, an iCardiac Certified Site is authorized to offer iCardiac’s 100% Risk Sharing Program for ECG analysis in TQT studies. For details on this unprecedented program, please contact us for more information.
The Certification Process
iCardiac initiated its certified site program to ensure that each study is conducted in an optimal manner that leads to the highest data quality. The certification program requires each site to go through an extensive training and testing process:
- On-site training by iCardiac personnel
- Site training for multiple personnel at each site
- Equipment deployment leveraging the same ECG/Holter acquisition technology utilized in the original validation study
- Demonstrated ECG precision to meet the highest quality standards
Becoming an iCardiac Certified Partner SiteFor information on joining this program as a provider, please contact your iCardiac representative
About Early Precision QT
Early Precision QT is the most broadly validated methodology for obtaining unmatched QT precision from a Phase I study. It is a proprietary, patented process built on over 30 years of leading research, and its performance has been documented in numerous peer-reviewed publications. The methodology analyzes ~10x more ECG data compared to the conventional measuring processes. The use of more data – as well as data that is less affected by signal noise and heart rate changes – results in significantly less variability, a critical element in achieving statistical significance from a typically-sized Phase I study.