Cleveland Clinic’s Vascular Core Laboratory (VCL) combines clinical, research and imaging expertise in vascular surgery with a track record of clinical trials management, all with the goal of helping industry and contract research organizations conduct efficient and successful clinical investigations.
As part of the Department of Vascular Surgery within Cleveland Clinic’s renowned Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute, the VCL is well-equipped to support all your needs relating to basic and clinical research as well as multicenter trials, including:
- Core laboratory medical imaging analysis
- R&D support
- Clinical trial data management*
- Project and site management*
- CEC, DSMB, and Executive and Steering Committees*
- Graphics and design*
*Provided through a collaboration with Cleveland Clinic Coordinating Center for Clinical Research (C5Research).
Core Laboratory Imaging Analysis
Our Vascular Core Lab (VCL), overseen by Cleveland Clinic physicians with expertise and board certification in vascular surgery, radiology and other specialties, has more than 20 years of experience providing independent, unbiased interpretation of CT, X-ray, MRI, angiography, and ultrasound imaging for clinical trials. Specific offerings include:
- Image tracking and compliance
- Electronic imaging submission
- Development of imaging analysis requirements and definitions
- Advanced 3D/4D imaging analysis techniques
- Rapid screening review to determine anatomic subject eligibility
- Custom imaging analysis to support R&D needs
By using our VCL, you can:
- Reduce interobserver variability. We use computer-assisted analysis techniques, study-specific analysis definitions, uniform imaging analyst training and variability testing to ensure analysis results have the highest standards. Additionally, core lab personnel can be blinded to treatment regimen and device use more readily than study personnel at the enrolling institutions.
- Establish and oversee compliance with imaging protocol guidelines. All imaging data is screened upon arrival to ensure adequate image quality and compliance with the imaging protocol.
- Ensure subjects meet anatomic inclusion criteria. Our rapid review of screening imaging can verify whether a subject meets anatomic inclusion criteria for your study as quickly as the same business day.
- Transfer imaging electronically. We use electronic imaging transfer with automated subject de-identification to rapidly obtain imaging while reducing HIPAA privacy risks. Imaging can be sent to us from any global location within minutes.
- Provide quality assurance. Every exam undergoes a multistep review process to ensure quality analysis results. Our experienced imaging analysts perform qualitative and quantitative analyses specifically designed for each protocol, with all results corroborated by a physician. Final results are provided to the sponsor through an electronic database or a hard-copy case report form.
Research and Development Support
The Vascular Core Lab (VCL) can support your R&D team by providing highly accurate anatomical models with detailed three-dimensional geometries of nearly any anatomical structure. Geometries are obtained from medical imaging (CT, MRI, etc.) identified by the VCL that meets predefined anatomic and disease criteria. The required anatomic surface or volume is then converted to a sharable digital format (e.g., STL file) compatible with engineering and modeling software.
Specific offerings include:
- Ability to model any anatomical structure needed (cardiovascular, orthopedic, etc.)
- Accurate 3D anatomic geometry surfaces and volumes
- Biomechanical 4D characterization
- Generation of digital files from medical imaging (CT/MRI)
- Ability to model normal, diseased and device-implanted anatomy
- Digital files to support engineering, computer modeling and 3D printing
- 3D printing
Clinical Trial Data Management
Experienced, knowledgeable data management experts provide the following high-quality services:
- Case report form development
- 21 CFR 11–compliant database design
- Development of data management plans
- Data tracking
- Data edit checks/validation
- Discrepancy resolution
- Data extraction, lock and transfers
Trials are managed from startup to closeout by following GCP and ICH Guidelines.
Project and Site Management
Our staff has extensive clinical and research expertise to assist with cost-effective and efficient study design and site management services. You will be assigned a designated project manager as your primary contact. Each site will be assigned a site manager for individualized communication, identification and resolution of study-related questions and issues in a timely manner. Services include:
- Informed consent template development
- Protocol and case report form development
- Site selection and site management
- Study team training
- Development of educational tools for use by site study team
- Assistance with IRB and/or other regulatory issues
- Study investigator and/or coordinator meeting planning and execution
- Site study team training or hosting informational webcasts
CEC, DSMB, and Executive and Steering Committees
We can assist in the selection, management and coordination of Data Safety Monitoring Boards (DSMB), Executive Committees and Steering Committees, including creation of the charters/guidelines to operationalize these committees. We also can provide Clinical Events Committee (CEC) services with an independent blinded analysis to determine trial endpoints and events.
Our staff has extensive clinical and research expertise to assist with the analysis of clinical trial data to help support summary activities ranging from regulatory reporting to manuscript preparation. Services include:
- Protocol design and review
- Sample size determination
- Statistical analysis planning
- Independent validation of results
- Statistical support for manuscripts
Graphics and Design
Our on-site graphics team can add that professional touch to your trial materials. Our talented degreed professionals can assist with guides, training materials, figures for manuscripts or podium presentations, newsletters, brochures and any other digital/print items needed.
Cleveland Clinic’s Vascular Core Laboratory offers cutting-edge imaging analysis, providing unbiased interpretation of CT, X-ray, MRI, angiography and ultrasound imaging for clinical trials. Among our faculty, you will find nationally and internationally recognized thought leaders in vascular surgery and other fields who initiate, lead and participate in a broad spectrum of studies. To learn more about how our Vascular Core Laboratory can support your research needs, please contact:
Paul Bishop, PhD, RVT
Director | Vascular Core Laboratory
Sean P. Lyden, MD, FACS
Chairman | Department of Vascular Surgery