Cardiac Safety Expertise
Cardiac Safety Consultation
Jay W. Mason, MD
Cardiac safety strategy from preclinical through Phase IV — serving pharmaceutical, biotech, and medical device companies and regulatory agencies worldwide.
Jay W. Mason, MD
Mason Cardiac Safety Consulting
Cardiac Safety Consulting Services
Protocol Design
Design and review of cardiac safety protocols for clinical trials
Statistical Analysis of ECG and Other Cardiac Safety and Efficacy Data
Rigorous statistical evaluation of electrocardiographic and cardiac safety data across all trial phases
Clinical Assessment of Cardiac Findings
Expert clinical interpretation of cardiac findings with regulatory-grade documentation
Expert Reports
Comprehensive expert reports for regulatory submissions, litigation support, and advisory boards
Support at FDA Meetings
Strategic preparation and direct participation in FDA advisory committee and pre-submission meetings
Assessment of Cardiac Equipment and Service Vendors
Evaluation and qualification of ECG equipment, core labs, and cardiac safety service providers
Jay W. Mason, MD
Mason Cardiac Safety Consulting
Cardiac safety expertise spanning preclinical through Phase IV — protocol design, ECG analysis, FDA support, and expert reporting. Trusted by pharmaceutical companies, biotech firms, and medical device manufacturers worldwide.