Our clinical team members bring an average of 20-years of experience, working with both drugs and devices, conducting and supporting trials in various roles, including Clinical Research Assistants (CRAs). We will support you through the steps for protocol development, navigating the IRB approval process, as well as overall engagement and management.
At our Independent Diagnostic Testing Facilities (IDTFs), the data is validated with subject identifiers that are compliant with the Health Insurance Portability and Accountability Act of 1996, (“HIPAA”), and the data is processed through our cloud-based, FDA-cleared proprietary BeatLogic suite of algorithms for highly accurate ECG analysis. Our services and technologies also follow General Data Protection Regulation (“GDPR”) enacted to protect the privacy of all individuals in the European Union and addresses export of the data outside of the European Union.
We are committed to reducing costs while driving higher study subject compliance, helping study sponsors move away from the traditional “study subject to study site” requirements and supporting pragmatic trials and real-world evidence requirements.
Preventice monitors support all remote monitoring service types (i.e. Mobile Cardiac Telemetry, Event, Holter or post-event monitoring) using state-of the art-technology for data acquisition per protocol requirements.
To give you peace of mind, all diagnostic data are analyzed by Certified Cardiac Technicians and Certified Rhythm Analysis Technicians at Preventice Independent Diagnostic Testing Facilities (IDTF) led by a board-certified doctor. Our team receive and analyze ECGs 24 hours per day, 7 days per week, 365 days per year.
Customized reading methodologies are offering using various degrees of automation and manual application to meet regulatory needs. Analyses include interval measurements, such as PR, RR, QRS, QT, QTcB and QTcF, QT correction formulas, and other clinical ECG interpretation.
ECG INSIGHT®, Preventice's cloud based system, offers you near real-time beat-to-beat data in telemetry mode
Export raw data in a comma separated value format for discrete data analysis, algorithm development, or tracking
Intuitive navigation to different times using calendar and time features
With one click, enable timely follow-up care and see every beat in near real-time
Approximately 70 percent of study participants live greater than two hours from study sites. Designed for use with the BodyGuardian® remote monitoring system PatientCare, cloud-based HIPAA-compliant selfmanaged platform, allows the principle investigator and their study team to gather, interpret and manage patient data independently and significantly reduces the need for multiple site visits throughout the study period. BodyGuardian® remote monitoring system allows a study participant to remain active and independent while being monitored.
PatientCare export via Application Programming Interfaces makes the data available for a third party to use. This capability enables study sponsors and clinical research organizations to connect the exported data to other electronic systems. Data is exported via web services into streams of discrete measurement data that can be parsed and leveraged in many different ways.