Uniquely Qualified to Address Your
Cardiac Safety Needs
- Cardiovascular core lab services can be used as an integral piece of the Medpace full-service CRO product offering, or as a stand-alone service
- Leverage the resources of a mid-size global CRO
- Unparalleled in-house medical expertise; physicians and cardiology specialists on staff with excellent peer to peer relationships with KOLs
- Extensive global experience with trial design, data interpretation and analysis, global study management, and regulatory strategy consultation
- Phase I-III capabilities for multi-centers and global studies
- Provides ECG acquisition and analysis services utilizing industry standard devices and systems, allowing ECG results to be interpreted in the context of all the other data
- 60,000 sq.ft. Phase I Unit on campus with systems designed for TQT studies tightly integrated with the core lab
Medpace Core Labs provides centralized acquisition and analysis of:
The device is a 12-lead diagnostic electrocardiograph used for acquiring on-site or remotely at patient’s home – with the help of a Home Health Nurse, viewing, and printing adult and pediatric 12-lead ECG data with in-built ECG interpretation for immediate review by Site PI.
The H12+ is a compact, non-invasive10-wire patient cable that allows recording of 12-lead continuous ECG. The device can record up to 48 hours of continuous data stored within the memory of the device.
We offer solutions for remote cardiac monitoring with 12 lead, 3 lead or single lead wearable patch devices for event-based and/or continuous ECG recording. These systems integrate seamlessly with the Core Labs trial management system to provide continuous data capture, compliance monitoring tools and central ECG review. We can also work on building customized remote cardiac monitoring solutions for your trial.
The ABPM 7100 is an easy-to-use, compact and non-invasive 24-hour ambulatory blood pressure monitoring (ABPM) system.
A digital blood pressure monitor intended for office or in-home use with automated data uploads and monitoring.
- Protocol design services by a team of Medpace medical, statistical and regulatory specialists ensure all aspects of cardiac safety and efficacy are considered and addressed in one package
- The same team can provide protocol review services and suggest efficiencies or improvements to an existing design, resulting in reduced budgets and proper data collection/power for regulatory submission
- Medpace is an executive committee member of the Cardiac Safety Research Consortium, and has extensive experience in the design of TQT studies
- Medpace can also help you determine whether your drug may be a candidate for an alternative Exposure/QT response study, obviating the need for a TQT, and saving significant time and money in establishing the cardiac safety profile of your compound
- Medpace operations in over 50 countries ensure your study will receive the attention needed, should higher than normal levels of support be required
- Medpace global equipment logistics experience ensures your devices will arrive at investigator sites when and where needed, without customs/duties related delays
- Localized training support to keep sites engaged and educated in proper acquisition and transmission of critical study data
- Localized Medpace site support can be employed to resolve any issues that may arise during the course of a study
- 24x7x365 Technical Support is available, ensuring timely resolution of support needs
- Industry standard Welch Allyn/Mortara Instrument ECG and blood pressure devices provide validated performance for high quality data
- Electronic transmission of data allow expedited receipt of digital data at the ECG core lab for timely analysis
- US Board Certified Cardiologists read every study, ensuring high quality expert analysis
- Industry standard electronic analysis tools allow precision that paper based studies can’t provide
- Medpace validation of systems ensures proper qualification of tools and methodology
- 21 CFR part 11 compliant systems ensure every action taken within the analysis of data is electronically documented and can be reviewed upon request
- ClinTrak database integration provides review of results in the same system as all other study parameters contracted with Medpace for a comprehensive view of study progression and outcomes
- The Medpace team will compile the statistical results and resulting medical conclusions and medical writing services needed for regulatory submission, and if required, work with your team to present the data to regulatory bodies
- Medpace Cardiovascular Core Lab is a Mortara Certified Partner, and can upload TQT and Exposure/QT response data into the FDA’s ECG Warehouse, as well as providing access to the data and review tools the FDA reviewers will use, prior to actual data submission