Mortara Certified Partner
iCardiac Technologies is a Mortara Certified Partner for the electronic submission of ECG information into the FDA ECG Data Warehouse. The certification covers iCardiac’s COMPAS technology platform, which is used for the automated and advanced analysis of ECG and Holter data.
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Charles River Laboratories
iCardiac Technologies has a partnership with Charles River Laboratories to provide world class Phase I capabilities for early stage cardiac safety characterization as well as for conducting Thorough QT (TQT) studies.
Charles River Website, click here.
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Prism Research
iCardiac Technologies has a partnership with Prism Research to provide world class Phase I capabilities especially in relation to special populations for early stage cardiac safety characterization as well as for conducting Thorough QT (TQT) studies.
Prism Research Website, click here.
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Dedicated Phase I
iCardiac Technologies has a partnership with Dedicated Phase I, which specialize in early clinical research services, with innovative technologies and proven expertise to speed the trial process from First-in-Human through to Proof of Concept. Dedicated Phase I is focused and committed to medical science, advanced technology and talented people, is a unique partner Dedicated to providing exceptional service and delivering impeccable data for your clinical trial.
Dedicated Phase I Website, click here.
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University of Rochester: Telemetric and Holter ECG Warehouse (THEW)
iCardiac Technologies, Inc. is a founding member of the Telemetric and Holter ECG Warehouse (THEW). iCardiac has participated in the development of the THEW through both technology and financial contributions and has been involved in the analysis of various ECG data sets now stored in the THEW databases.
Striving to advance the field of cardiac safety, the THEW initiative is developed under an agreement with FDA for facilitating collaborative discussions between THEW members, and for leveraging resources to implement joint projects among FDA, UR, and other public and private stakeholders. THEW is a publicly accessible data warehouse where scientists from academia, industry, and government can develop and test new computer algorithms related to quantitative electrocardiography:
- Designed to inform cardiac safety and medical product development, the THEW enables access to unique data and tools to develop automatic ECG analysis algorithms.
- Current research projects aim at increasing QT measurement accuracy used in drug safety trials, which would result in smaller, faster, and therefore more cost- and time-effective drug development processes.
- Better ECG markers and high precision detection techniques will benefit all stakeholders by ensuring that unsafe drugs do not get to market, while reducing the chances of a “false positive” signal.
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Pfizer: iCardiac Technologies Enters into Non-Exclusive Cardiac Safety Alliance with Pfizer
In 2006, iCardiac Technologies entered into a multi-year research alliance with Pfizer Inc. to develop and validate advanced ECG-based cardiac safety biomarkers utilizing iCardiac’s COMPAS technology platform. The aim of the research alliance is the creation and implementation of new biomarkers, for use in clinical trials, that will enable pharmaceutical companies to better assess the cardiac safety profiles of their in-development and on-market drugs. The alliance includes a cross-licensing arrangement by which iCardiac has received rights to ECG analysis technologies developed within Pfizer for integration within iCardiac’s technology offering to the industry.
For press release, click here.
For press coverage, click here.
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4Qimaging, LLC
iCardiac Technologies has partnered with 4QImaging to offer end-to-end imaging core lab services for musculoskeletal Phase I to Phase IV clinical studies in a fully regulatory compliant setting. Researchers comprising 4QImaging have developed CiPAS (Clinical Image Processing and Analysis System), the industry’s most sophisticated highly automated approach to reproducible analysis of musculoskeletal MRI images to support pharmaceutical and medical device companies’ clinical development programs for arthritic diseases and cartilage repair products. The automated system provides simultaneous quantitative analysis of over 800 compositional, structural, and morphological cartilage, bone, and soft tissue biomarkers. CiPAS has been extensively validated and has so far been used in over 15,000 image analyses. All agency facing studies using CiPAS are conducted in iCardiac’s fully regulatory compliant core lab setting in partnership with 4QImaging.
4Qimaging Website, click here.
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University of Rochester: The Heart Research Follow-up Program
The core technology of iCardiac was originally developed based on research conducted at the Heart Research Follow Up Program (HRFUP), a part of the University of Rochester Medical Center. iCardiac holds an exclusive license for the core technology and maintains a close collaborative relationship with HRFUP.
HRFUP, which is funded in part by National Institutes of Health grants, is a national and international leader in the science of heart arrhythmias and a rare genetic condition associated with an abnormal QT interval, called the congenital Long QT
Syndrome (LQTS). HRFUP has been conducting research in the area of heart arrhythmias for nearly 30 years and maintains a staff of over 40 researchers. As a key academic research and clinical resource, the university keeps an International Registry for LQTS, and follows thousands of families who have this inherited condition. One of the
genetic forms of the QT prolongation syndrome is highly similar to the drug-induced syndrome, and the university's work focuses on developing the tools to identify individuals with either form.
