ECHO/MUGA Services

Consulting

Cardiocore’s scientific experts assist sponsors in developing advanced and efficient strategies for echocardiography. Pre-study consulting services include strategic planning, protocol review, protocol development, and regulatory assistance. These services are available for Phase I-IV studies.

Project Management

Cardiocore implements projects in three distinct phases— Planning, Execution and Control, and Closing.  The company’s Project Management SOPs (standard operating procedures) 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 sponsor. 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.

Customer Support

Depending on individual sites’ system capabilities, Cardiocore provides DVDs, CDs, or VHS tapes for ECHO recordings.

Global Logisitics

Cardiocore employs the major shipping and expediting services for international deliveries, and has experience with customs approvals and site provisioning in nearly sixty countries, on six continents, across 21 time zones. 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

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 are designed to ensure that the site staff:

• Understands how to acquire the necessary ECHO 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 study services

ECHO Analysis

Cardiocore maintains a state-of-the-art echocardiography processing system. This DICOM-compliant system accommodates medical analyses, database security, and data management for both digital and analog files. The system is designed to accommodate global sites that use virtually any type of ultrasound equipment to acquire echocardiographic images. Sites may submit digital data via DVD/CD or analog data on VHS tape. Analog inputs may be reviewed in their native state or may be converted into digital image files. At Cardiocore, experienced medical doctors perform all ECHO analyses including quantification of cardiac chamber size, ventricular mass, cardiac function, volume, and wall thickness. Display modes include 2-D, M-Mode, Doppler, or Tissue Doppler. These procedures are based on American Society for Echocardiography guidelines, which are widely applied to clinical research and clinical practice.

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, ECHO methodologies, study design details, and scientific conclusions.