Vascular Surgery Academic Coordinating Center (VSACC) & Peripheral Vascular Core Lab (PVCL)

Transcription

1 Vascular Surgery Academic Coordinating Center (VSACC) & Peripheral Vascular Core Lab (PVCL)

2 What are the VSACC and the PVCL? The Vascular Surgery Academic Coordinating Center (VSACC) is an academic research organization (ARO) and the PVCL is a peripheral vascular core lab within the Cleveland Clinic Department of Vascular Surgery. We combine clinical, research and imaging experience in vascular surgery with management expertise to help industry and contract research organizations conduct efficient and successful clinical trials.

3 Why Choose the VSACC and the PVCL? The VSACC team has extensive experience in organizing and managing clinical trials, ranging from smaller single center trials to large-scale multicenter trials. The PVCL offers cutting edge imaging analysis providing unbiased interpretation of CT, X-ray, MRI, angiography and duplex ultrasound imaging for clinical trials. Among our faculty, you will find nationally and internationally recognized thought leaders in the vascular surgery field, who initiate, lead and participate in a broad spectrum of studies. The VSACC is recognized by the Society of Clinical Data Management as a Certified Clinical Data Manager Industry Master.

4 Services The VSACC offers a wealth of services including: Clinical Data Management Experienced, knowledgeable and certified data management experts provide the following high-quality services: CRF development 21 CFR 11 compliant database design using CDISC model Development of Data Management Plans including CRF and data flow designs, responsibility matrix, scope of work, communication plan and contact matrix, Quality Assurance and database validation Data tracking Data edit checks/validation Medical coding (MedDRA) Discrepancy resolution Data extraction, lock and transfers Trials are managed using paper or electronic case report forms from start-up to close out, following GCPs and using the SCDM Good Clinical Data Management Practices Guidelines.

5 Project & 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 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 Benefits We can help build a customized plan of data, project and site management services that best suits your needs, which can: Improve trial coordination We provide specialized help coordinating trials between sponsors, CROs and sites, while assisting with protocol and CRF development, site qualification and selection. Reduce recruitment and/or retention issues We help identify and resolve concerns at the site level. Handle reporting and communications with other agencies We can help with tracking and reconciling adverse event reports and work with the Steering Committee, Data and Safety Monitoring Board (DSMB), and Clinical Events Committee (CEC) as needed.

6 The PVCL offers a wealth of services including: Peripheral Vascular Core Laboratory Our Peripheral Vascular Core Lab (PVCL) has more than 10 years of experience providing independent, unbiased interpretation of CT, X-ray, MRI, angiography and duplex ultrasound imaging for clinical trials, including: Film tracking and compliance Development of analysis definitions Database programming Advanced 3-D imaging techniques

7 Benefits By using our PVCL, you can: Reduce inter-observer variability We use computer-assisted quantitative analysis techniques, a consistent set of analysis definitions, uniform technician training and variability testing. 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 Our lab can process imaging data received on cut flat films, DICOM format and video tape. All imaging data is screened when it arrives to assure adequate image quality and compliance with the imaging protocol. Provide quality assurance Every exam undergoes a multistep review process to ensure quality analysis results. Our experienced technicians 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 hard copy case report form. Get Involved To learn how the VSACC can work for you, call Lori Vivian at For more information on our PVCL services, contact Paul Bishop at

8 CONTACT US: Vascular Surgery Academic Coordinating Center (VSACC) Lori Vivian, BSN, RN, CCRP Research Program Manager 9500 Euclid Avenue (JJ35) Cleveland, OH P F vivianl@ccf.org Peripheral Vascular Core Lab (PVCL) Paul Bishop, MSEE, RVT Research Program Manager Senior Research Engineer 3050 Science Park Drive (AC3-24) Beachwood, OH P F bishopp@ccf.org clevelandclinic.org/vsacc