Cardiovascular Safety Services

Early Phase Cardiovascular Safety Research

Celerion leverages its experience, expertise and specially equipped facilities to offer a wide range of cardiovascular safety studies. Celerion is a leading provider of cardiovascular safety services in early clinical research, with over 40 years of clinical research experience, including 100s of studies to evaluate cardiovascular liability, and more than 60 Thorough QT (TQT) studies completed.

Comprehensive Cardiovascular Safety Assessment

Precise evaluation of the QT interval is important in evaluating arrhythmia potential of a compound. However there are multiple off target effects of compounds which may require a more comprehensive assessment of cardiovascular safety. To address these Celerion offers a range of services, including:

• TQT and Exposure response modeling
• Non-invasive cardiac imaging
• Physiologic stress testing
• Platelet aggregation
• Ambulatory blood pressure monitoring
• Real-time telemetry monitoring
• Cardiac serum biomarkers
• Central over-read of ECGs

Comprehensive Clinical Services

Celerion provides all support services for early clinical studies including protocol development, bioanalysis, statistical analysis and report writing, giving you the ease and economy of working with one vendor for all study needs. Our flexibility enables us to efficiently conduct studies of varying size while maintaining strict data quality and patient safety standards. We have conducted a broad range of TQT studies performed involving
50 to 250 participants. We make sure that you receive fast accurate results. Our U.S. Board certified cardiologists have over 25 years of industry experience reading Holter and ECG data for the pharmaceutical industry with results that exceed industry standards.

Our industry leading highly automated ECG Core Lab reduces both time and cost for analyzing ECG data while ensuring the highest level of accuracy and precision. Celerion’s ECG Core lab senior staff has more than 15 years of experience working with regulatory authorities and assisting with study design, data analysis, and expert report writing.

• Over 40 years of experience: Conducting First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and clinical pharmacology research supporting product labelling
• Extensive expertise: On modelling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis
• Highly qualified scientists: Assist in designing robust, efficient clinical studies as well as analyzing and interpreting data both during and post clinical conduct
• Bioanalytical services: Two global locations for method development and validation for small and large molecule assays for the analysis of drugs, metabolites, and biomarkers in a broad range of biological fluids
• Drug development services team: Provides regulatory, drug development and program management support to complement Celerion’s clinical service offering