ECG Services
Consulting
Cardiocore’s scientific experts assist sponsors in developing advanced and efficient strategies for ECG testing. 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 Standard Operating Procedures (SOPs) 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 sponsor collaboration. Projects begin with formal kick-off meetings. Procedures are tracked daily, reports are published weekly and metrics are measured continuously. Final checklist and formal close-out meetings ensure that projects end on time with comprehensive documentation.
Digital ECG Equipment
Cardiocore provides state-of-the-art, 12-Lead digital cardiographs for clinical trials. Equipment models include the Mortara ELI 250, Mortara ELI 150 and the GE Medical MAC1200. These units accommodate push-button digital data transfer, instantaneous ECG printouts for site personnel and storage capacity up to 150 ECGs. Cardiocore provides barcode scanner attachments for ECG-intensive studies.
Paper ECG Processing
When paper ECG processing is required in a retrospective or prospective clinical trial, Cardiocore uses the industry-leading ECG Scan system from AMPS LLC, to digitize the hardcopy images, then performs digital analyses using on-screen calipers. This process enables Cardiocore to provide digital output, including files conforming to the FDA HL7 aECG Standard, from paper inputs. When requested, Cardiocore also provides traditional manual paper ECG analysis using the loupe method.
Customer Support
Cardiocore’s customer support staff pre-configure cardiograph devices to enable easy digital transfer of ECG data from the site to Cardiocore’s protocol-specific database. Quality assurance testers examine each device prior to shipping. Equipment deliveries include enough ECG-paper, electrodes, razors, manuals, quickguides and other supplies necessary to support the study’s ECG acquisition requirements. Cardiocore employs the major shipping and expediting services for international deliveries and has experience with customs approvals and site provisioning in nearly fifty countries, on six 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. 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 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
ECG Analysis
Cardiocore maintains the industry’s largest team of board certified cardiologists to precisely measure and interpret sponsors’ ECGs. Based on protocol requirements and sponsor preference, Cardiocore offers several ECG reading methodologies using varied degrees of automation and manual application of cardiologist expertise. ECG analyses typically include morphological interpretations, PR, RR, QRS, QT, QTcB and QTcF. QTcI, other QT correction formulas and less-common cardiac safety biomarkers are provided when appropriate.
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, ECG methodologies, study design details, QT correction details, interval data, stratification, endpoint information and scientific conclusions.