Core Lab Services

As cardiac safety thought leaders iCardiac scientists bring deep academic and drug development knowledge to each project. Our experts remain accessible to sponsors at all times. We cover all the critical issues, such as ensuring your cardiac safety study conforms to ICH E14 requirements. What differentiates iCardiac’s approach, however, is our ability to integrate non-clinical information and experience with particular drug classes or therapeutic areas to optimize the efficiency and quality of a clinical study. iCardiac scientists have worked on CV safety assessment for more than 200 drug candidates and more than 20 marketed drugs. We provide initial consultation to identify issues that may arise in executing a clinical study and full protocol development services upon request. In addition to clinical study design services, we can recommend supplementary, non-clinical data that may strengthen regulatory submissions.

iCardiac’s Site Management group has conducted numerous cardiac safety studies from in all phases of drug development. iCardiac has orchestrated large multi-site international ECG/ABPM clinical trials and worked with leading pharmaceutical companies in a wide range of therapeutic areas.

• Data Collection
        • ECG, Holter, and ABPM equipment training
        • Patient preparation
        • Patient hook up
• Site training, testing and certification
        • Develop site operations manual
        • Train the clinical site on all aspects related to the ECG, Holter or ABPM data acquisition
      • Review test data and all in-coming data to ensure site is properly trained and the data quality is maintained           throughout the study
• Deployment of all equipment and supplies to sites globally
• 24/7 customer assistance

Ambulatory Blood Pressure Monitoring (ABPM)

iCardiac Technologies provides a unique combination of Ambulatory Blood Pressure monitoring equipment and a customized interface for each investigative site that participates in a clinical trial involving the collection of ABPm data. The interface manages the ABP monitoring process at the investigative site, and retains all of the data recorded during the term of the trial so that it can easily be recalled by the site personnel. Subject demographic information is entered only once, and the interface provides immediate confirmation on technical and other customized study success criteria. We can support both single and multisite domestic and international studies with standardized equipment, customized training modalities, and 24/7 customer service.

Data Management Group

The iCardiac core lab is continually focused on maintaining high quality data. We proactively monitor signal quality and conduct demographics checks for all studies. We operate in access-controlled facilities and perform regular data back up and store data off site. iCardiac practices role-based access control to protect project data.

iCardiac enjoys a 100 percent success rate in customer audits which include the world’s top five pharmaceutical companies.

Core Lab Analytics

iCardiac’s next generation core lab combines the efficiency and reproducibility of automated approaches with the benefits of expert human oversight. iCardiac analytics feature the most advanced and validated software in the industry. iCardiac offers the industries widest range of interval analysis with QT, QRS, and PR interval analysis.

Where diagnosis of heart condition is indispensable to the interpretation of results iCardiac offers diagnostic interpretation of ECGs. In addition, iCardiac provides arrhythmia monitoring services.

Project Managment

Interim Reporting
iCardiac provides thorough and accurate reporting throughout the study process including timely reports for dosing studies which support fast turnaround and interim decision making.

Statistical Analysis and Expert Reports
The iCardiac team provides robust results as well as expert reports for regulatory submissions. By working with iCardiac you can ensure study reports will be done correctly the first time.