Cardiovascular Core Lab provides different services as provided below.
- Protocol Development
- CRF Development
- SOP Development
- Clinical Site Training
- Image Management
- Image Analysis
- Data Management Reports
Protocol Development
The staff and physicians in the Cardiovascular Core Laboratories are available to review the clinical trial draft protocol and provide input to ensure imaging requirements are appropriate to optimize the likelihood of completing the study in an effective and efficient manner. The Core Lab will review all aspects of the study protocol and provide expertise and advice in regards to imaging; the staff will collaborate with sponsors to develop imaging acquisition protocols for each study, as needed and appropriate. Drawing on their years of experience and knowledge of FDA guidelines, the staff is instrumental in formulating instructions for sites acquiring images. These instructions usually address equipment requirements, personal experience or certification and a detailed 'menu' of how to acquire the images. The key parameters in the imaging protocol and analysis need to match the goals and objectives of the clinical trial. Often there needs to be a balance between a focused exam that assesses the required fields only versus one that is broader and collects several other parameters that could have potential value in the future. We will discuss the pros and cons of each approach and offer our advice based on the strengths and weakness of the imaging modality and on how those fit your trial objectives.
CRF Development
The physicians and staff in the Cardiovascular Core Labs are available to support the creation of study-specific case report forms. CRFs for the clinical sites are designed to help improve compliance with the acquisition protocol. They often involve a 'checklist' and on-site measurements of key fields. The Core Lab will also develop a data transfer (or Core Lab) case report form with all the analysis fields performed. This will be developed, in collaboration with the sponsor, to ensure all data that relates to study primary and secondary endpoints that are image-related are appropriately captured.
The Cardiovascular Core Labs can use either electronic or paper CRFs. The lab has partnered with commercial vendors to implement eCRF's that can be housed within the Core Lab or web-based. Electronic CRFs utilize drop-down menus and 'gray-out' functions to ensure complete and accurate data collection. Electronic-based CRFs may be customized to meet the sponsor's needs and have many advantages such as reduction of data queries, streamlined data transmission and implementation of real-time data quality assurance measures.
Study-Specific SOP Development
The physicians and staff of the Cardiovascular Core Labs work with sponsors to develop study-specific Standard Operating Procedures for the Core Lab image analysis. These SOPs include step-by-step procedures performed in the Core Labs, including project management, study tracking, image processing and analysis, data management and quality assurance. All aspects of image and data management are documented in the SOP and are available to the study sponsor for review. The SOP ensures documentation of all aspects of the Core Lab activities for your study and also ensures compliance with regulatory agencies.
Clinical Site Training
Training has become a required aspect of clinical trials that utilize imaging. The physicians and staff of the Cardiovascular Core Labs will develop training materials to ensure all investigators are familiar and appropriately trained on the imaging acquisition protocols. "Self-study" Microsoft Powerpoint presentations can be used for relatively simple, clinically relevant acquisition protocol. These slideshows present side-by-side acquisition instructions and images. This is often a good way to ensure that physicians, sonographers /technicians and staff know and understand the acquisition protocol. These presentations can be used during site initiation and may be combined with a conference call or web-based training sessions. Often training will take place at an investigators meeting. The Core Lab staff is available to participate in this training session and can provide 'take home' material that reinforces the key points made during the presentation. In addition, the staff is available for on-site training for PIs and study staff. This is appropriate for more demanding acquisition protocols or when the imaging component of the study protocol is critical to the successful implementation of the study. Depending on the scope of the imaging requirements, we may suggest that sites provide a qualifying study before they can begin enrollment. We will ensure timely assessment of these studies and discuss issues that arise during their review.
Image Management
1) Image tracking
The Cardiovascular Core Labs use a customized bar-coded tracking system to aid in the identification and tracking of studies. All videotapes, CD's or MO discs are logged into the Cardiovascular Core Labs' tracking system upon arrival. The system generates a unique bar-coded label and identification number for each study.
Labels are attached to the tape/CD and all associated paperwork. A letter noting confirmation of receipt of each study can be generated and faxed to the clinical site upon arrival of the study to the Core Lab. As the study moves to the technician and physician, it gets tracked (bar code scanners are associated with each step in the analysis). The system allows immediate identification and status of any study within the system and allows generation of status reports for the sponsor. These reports can be produced at pre-determined intervals or upon request.
- DVD
- CD
- Optical Disk (MO)
- VHS video tape (NTSC or PAL or SECAM format)
- SuperVHS video tape (NTSC or PAL or SECAM format)
Any video tape received will be digitized and all images used for analysis will be saved as DICOM, jpeg, avi or bmp files.
2) Analog to digital conversion
While most imaging data is becoming digital, some IVUS and Echocardiography studies are still videotape (analog). We are capable of receiving image data in virtually any commercially available format, whether digital or analog. This includes the following media:
3) Digital web transmission
The Cardiovascular Core Labs have partnered with commercial vendors to offer the option of web-based digital transmission of echo studies. Studies can be submitted to the Core Labs via a secure web-site. Studies can be submitted from any desktop computer with internet access and the appropriate software. All studies are electronically archived on a secure server and are available for immediate review. For further information about this option, please contact the Core Lab.
4) Image Duplication and Storage
All images submitted to the Core Lab are duplicated and archived. This serves as the source documentation for our analysis. Digitized studies are copied onto a secure server that has nightly backup. Video tapes can be duplicated and stored (which become increasingly important when the original needs to be returned to the clinical site). Tapes/CDs are stored on-site for the duration of the study and long-term, if desired. All digitized images and measurements used for analysis will be stored digitally in duplicate; One copy is saved on the Core Lab server which is backed up nightly and the other copy is burned onto an external hard drive which is stored in a fire proof file cabinet.
Image Analysis
Initial image analysis is conducted by trained technicians / sonographers and reviewed side-by-side with an experienced cardiologist. Every study analyzed in the Core Lab is reviewed by a board certified Cardiologist. We believe that this is necessary to maintain quality and it provides the highest level of acceptability by regulatory agencies.
Image analysis is customized based on the protocol and the needs of the sponsor. The physicians and staff in the Core Labs are available to aid in identification of appropriate image analyses to support each study. Analyses include 2D and volumetric analysis, assessment of anatomy and physiology, assessment of function of the heart and/or implanted device. Given the very diverse nature of cardiovascular disease and the multitude of anatomic and physiologic parameters that can be measured with ultrasound, it is impractical to list all the possible parameters that could be measured. The scope of analysis will be determined after review of the clinical protocol and in collaboration with the sponsor.
Equipment
The Core Lab analyzes all studies using commercially available, 510K approved workstations. Cardiac ultrasound studies are analyzed on the the Phillips Enconcert System and the Digisonics Digiview Review System and IVUS studies are analyzed using the Indec system. Both echo and IVUS studies can be analyzed in NTSC, PAL or SECAM format (video) or in digital (DICOM) format using all types of media (CD, DVD or MO disk). All equipment is appropriately inventoried and maintained with monthly checks and logs to assure proper function. The Core Lab utilizes commercially available, 510K approved workstations for all image analysis.
Cardiac ultrasound studies are analyzed on the the Phillips Enconcert System and the Digisonics Digiview Review System. IVUS studies are analyzed using primarily the Indec system. Both echo and IVUS studies can be analyzed in NTSC, PAL or SECAM format (video) or in digital (DICOM) format using all types of media (CD, DVD or MO disk). All equipment is appropriately inventoried and maintained with monthly checks and logs to assure proper function.
Data Management Reports
Once a study has been analyzed, a data transmittal sheet/case report form is completed. Paper CRFs are copied and the original is returned to the sponsor or CRO. If an electronic CRF is used, the data will be downloaded directly into an Access database. All data is run through a quality control check to ensure all variables are within pre-determined guidelines. Once data has been verified, it will be transferred to the sponsor/CRO electronically. All data fields and parameters can be specified through a data transfer agreement to ensure smooth transmittal of the information. An on-site data manager and on-site statistical support is available for customized data management or analysis.
Customized Reporting
The Cardiovascular Core Labs can provide the sponsor/CRO with progress reports or statistical analysis reports throughout the study. The lab study tracking system can be used to provide progress reports at regular pre-determined intervals or upon request. These progress reports can list every study received by the lab and whether the analysis is complete or pending. As described above, an on-site data manager and on-site statistical support is also available for customized data management or analysis. We work closely with sponsors and clinical research organizations to perform timely analysis of the data and generation of reports (for example, an interim quality assurance report to determine the yield of a particular parameter on a site by site bases can be performed to determine if there is adherence to the imaging protocol). We will also work with your Data Safety and Monitoring Board to produce the interim reports necessary for their proper function. Final reports by a sponsor or CRO can also be reviewed and assistance in preparation for regulatory submission is available.