Core Lab
Clinical studies of new therapeutic approaches to stroke and ischemic heart diseases are key components of VIL’s research. The VIL Core Lab is a leading imaging core laboratory for cardiovascular atherosclerosis studies.
Our services include trial study design, multi-center imaging site preparation, image collection, central reading /analysis, and data management. We also develop medical image analysis tools and facilitate their commercialization for clinical use.
The VIL Core Lab consists of a team of specialists from radiology, neurosurgery, cardiology, histology, and image analysis. Our team has years of dedicated clinical trial experience in imaging services and studies, as well as state-of-the-art magnetic resonance imaging (MRI) and analysis technologies. These technologies are validated and meet 21 CFR Part 11 and other US and international regulatory requirements for clinical trials.
Our services include:
Trial Study Service
- Study design
- Endpoint development
- Imaging protocol development
- Site selection, setup and testing
- Study-specific training of site staff
- Provision or coordination of imaging equipment.
- Multi-center data collection management
- Image quality assurance
- Subject eligibility evaluation
- Centralized image reading
- Automatic biomarker analysis.
- Analysis reporting
- Integration with other databases
- Image and data archival services
- Statistics analysis
- Manuscripts
- Regulatory submission preparation.
- Aim High (NIH)
- Aim High Reproducibility (NIH)
- HRP (Abbott, AZ, BG Medicine, Merck, Philips and Takeda)
- ORION (AZ)
- Uppsala (AZ)
- Restore-IT (ActiveBiotics)
- Chicago Healthy Aging Study (UTSW)
- Dallas Heart Study (NIH)
- K-604-21 (Kowa)
- NWU-PAD (NIH)
- Three sites (Pfizer)
- REACH (AZ)
- CASCADE is a custom-designed software program which provides an array of automated and manual plaque measurement, registration, and image processing tools for use in clinical studies. It is tested and validated according to FDA guidelines for software programs in clinical trials.
- iCafe is a semi-automated artery modeling tool to analyze arteries from 3D vascular images, such as 3D Time-of-flight MRA. It quantitatively and comprehensively describes intracranial artery features which are important factors for brain health assessment.
- VTS is a custom-designed trial administration software which provides advanced image management capabilities for clinical trials. It is tested and validated according to FDA guidelines for software programs in clinical trials.