Holter Services
Consulting
Cardiocore’s scientific experts assist sponsors in developing advanced and efficient strategies for Holter monitoring. Pre-study consulting services include strategic planning, protocol review, protocol development, and regulatory assistance. These services are available for Phase I-IV and Thorough QT studies.
Project Management
Cardiocore implements projects in three distinct phases—Planning, Execution and Control, and Closing. The company’s Project Management SOPs (standard operating prcedures) are built on the principal that successful execution of the Planning phase is the most effective way to ensure flawless performance in the Control and Closing phases. Every Cardiocore project is governed by a detailed Project Charter that is developed through collaboration with the sponser. Projects begin with formal kick-off meetings, procedures are tracked daily, reports are published weekly, and metrics are measured continuously. Final checklist and formal closeout meetings ensure that projects end on time, with comprehensive documentation.
Digital Holter Equipment
Cardiocore provides state-of-the-art 12-Lead digital Holter monitors for clinical trials. Equipment models include the high-fidelity and regular-fidelity versions of the Mortara H12+ Holter recorder. The high-fidelity version of this device records continuous ECG data at 1,000 samples per second, enabling true one-millisecond resolution.
Digital Holter Data Transfer
When digital Holters are used in clinical trials, the data are recorded on flashcards. Typically, these flashcards are sent by overnight courier, from the investigative site to the core lab. This process exposes the Holter data to risk of delay, or even damage or loss in the mail stream. To protect source data, Cardiocore offers it’s advanced HolterGateway™ data transfer system. This touch-screen device enables site personnel to easily and securely transfer Holter data to Cardiocore via the Internet.
Customer Support
Quality assurance testers examine each Holter recorder and flashcard prior to shipping. Equipment deliveries include enough lithium batteries, electrodes, razors, manuals, quick guides and other supplies necessary to support the study’s Holter monitoring requirements.
Global Logistics
Cardiocore employs the major shipping and expediting services for international deliveries, and has experience with customs approvals and site provisioning in nearly 50 countries, on 6 continents. Customer Support services are available 24/7. Every site in every country receives a toll-free phone number for Customer Support access, and real-time translation services are available in 157 local languages.
Site Training
Cardiocore delivers equipment to the site prior to training, and assists the site staff to complete successful test procedures prior to transmitting actual study data. Training sessions are provided in three formats—in-person at Investigators Meetings, in-person at study sites, and via the Internet with a live trainer (CardioCourse™). Cardiocore’s training sessions cover the use of the equipment and protocol-related processes. Comprehensive Investigator Reference Manuals encompassing the services, and equipment for the study, are supplied for use by site personnel. Cardiocore’s training sessions are designed to ensure that the site staff:
- Understands the functioning of the equipment
- Understands how to prepare the skin and place electrodes
- Understands how to acquire and transmit cardiac data
- Understands the protocol’s cardiac safety requirements and time-point schedule
- Have all required contact information for Cardiocore’s protocol-specific team
- Have received the comprehensive Investigator Reference Manual encompassing
- the services and equipment for the study
Holter Analysis
At Cardiocore, Holter recordings are analyzed first by a cardiovascular medical doctors, then reviewed and authorized by a board certified cardiologist if required. Arrhythmia and Ischemia Reports include rate statistics, tachycardia/bradycardia episodes, supraventricular ectopy, ventricular ectopy, RR variability, ST deviation, pauses, rhythm profile, trends, and waveform examples.
Extraction of ECGs
For Thorough QT studies and other ECG-intensive trials, it is common practice to use Holter devices for continuous data acquisition, then to extract 10-second ECG segments for analysis per protocol requirements. Cardiocore often provides this service to help sponsors reduce costs and mitigate the risk of missed time points.
Expert Reporting
Cardiocore’s team of senior scientists and statisticians provide comprehensive Statistical Analysis and Cardiac Safety Reports. Along with comprehensive tables, figures, and graphs, these documents include statistical and analytical methods, Holter methodologies, study design details, and scientific conclusions.