Services

Services

Study Support

The Cardiovascular Core Lab at Morristown Medical Center is available to review the clinical trial protocol to ensure that appropriate echocardiographic imaging is obtained. In collaboration with the study sponsor, the Cardiovascular Core Lab develops study-specific echo protocols, typically incorporated into study-specific manuals. The Cardiovascular Core Lab also works with the sponsor to develop study-specific case report forms (CRFs). CRFs may be paper-based or electronic as required.

The day-to-day function of the Cardiovascular Core Lab is well-defined by a set of standard operating procedures (SOPs). These detailed documents outline virtually all aspects of our Cardiovascular Core Lab operations and help to provide a transparent, reliable set of guidelines for good clinical practice and regulatory compliance. For each study, the Cardiovascular Core Lab also generates study-specific SOPs to ensure appropriate data management and consistent image analysis and reporting.

The Cardiovascular Core Lab is also available to provide assistance in regulatory reporting and manuscript development.

study report

Site Training

Site training is an important part of any well-conducted investigation. The Cardiovascular Core Lab provides protocol-specific clinical site training using a variety of platforms. We are able to develop instructional live programs and webinars, web-based content, Microsoft PowerPoint presentations, DVDs and training manuals to assist sites with image acquisition. Our staff is also available for on-site training, as well as ongoing participation in investigator meetings.

The Cardiovascular Core Lab is available to answer any echo imaging questions that may arise over the course of the study.

site training

Image Management

All images are stored on a secure, dedicated Cardiovascular Core Lab server, which is backed up nightly by Atlantic Health System. Any study discs are saved in a secure on-site location. All image storage and management is done in compliance with CFR Part 11 regulations.

Image analysis is performed using the latest generation Philips, Siemens, GE and TomTec echocardiographic analysis software.

image management

Reporting

Following imaging analysis, all data is carefully transcribed to a paper or electronic Case Report Form. A study-specific echo review form is also generated with each study to provide constructive technical feedback to each clinical site. Composite report cards are also available.

reporting

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