The Medpace Cardiovascular Core Laboratory provides state-of-the art, standardized electrocardiogram (ECG) equipment and centralized electrocardiography data analysis to support Phase I-IV clinical trials around the world.
Working in collaboration with the medical and regulatory experts at Medpace, the Core ECG team – which includes board-certified cardiologists, ECG technicians, data assistants, system engineers – has extensive global experience with trial design, data interpretation and analysis, global study management, and regulatory strategy consultation.
As a Mortara Certified Partner, the Medpace Cardiovascular Core Laboratory uses state-of-the-art, validated technologies that meet HL7 standards requirements for annotated ECG, 21 CFR Part 11 criteria, and adhere to all US and international regulatory requirements. Our global standard operating procedures (SOP) ensure consistent, efficient, and comprehensive data that meet all Sponsor protocol requirements.
Every digital ECG is read by a board-certified cardiologist who follows strict quality assurance and confidentiality standards to maintain FDA and ICH compliant cardiac safety analysis. All ECG data are fully-integrated into Medpace's proprietary data management system, ClinTrak® DM, which enables the Lab to collect, interpret, and distribute cardiac safety and global clinical trial data more efficiently and provides Sponsors near real-time access to lab test results and data via a secure, web-based interface.
The advantages of the Medpace Cardiovascular Core Laboratory include:
- Quantitative ECG analysis for single center and multicenter cardiovascular clinical trials.
- All ECG activities, including site establishment, supplies, training, and data reconciliation and interpretation, are managed through a central data collection point.
- All ECGs are read by board-certified cardiologists.
- Digital ECGs are captured with state-of-the-art equipment and transmitted electronically to provide greater clarity.
- Certified to submit ECG XML data directly to the FDA via Mortara's E-Scribe ECG Warehouse.
- Near real-time access to ECG data via web-based, ClinTrak DM.
The Medpace Cardiovascular Core Laboratories' capabilities include:
- 12-lead Digital ECGs.
- 12-lead Digital Holter Analysis – 24 or 48 hour continuous monitoring of potential arrhythmias, myocardial ischemias, and ST segment analysis.
- Alert ECGs reviewed within 2 hours.
- Non-alert ECGs reviewed within 48 hours.
- Review the last 5 ECGs in a study at one time.
- Customizable Alert Criteria Notification dependent on Sponsor protocols.