Reading Center

Reading Center Img

 

Clinical studies of new therapeutic approaches to stroke and ischemic heart diseases are key components of VIL's research. The VIL Reading Center is a leading imaging core laboratory for cardiovascular atherosclerosis studies. Dongxiang Xu, PhD directs this group.

Our services include study design, multi-center site preparation, image collection, central reading /analysis, and data management.

The VIL Reading Center 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:

Software:
  • 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.
  • 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.
Pre-Study:
  • Study design
  • Endpoint development
  • Imaging protocol development
  • Site selection, setup and testing
  • Study-specific training of site staff
  • Provision or coordination of imaging equipment.
In-Study:
  • Multi-center data collection management
  • Image quality assurance
  • Subject eligibility evaluation
  • Centralized image reading
  • Automatic biomarker analysis.
Post-Study:
  • Analysis reporting
  • Integration with other databases
  • Image and data archival services
  • Statistics analysis
  • Manuscripts
  • Regulatory submission preparation.
The VIL Reading center has been involved in over 20 studies and clinical trials worldwide, including the North America, Europe and Asia, in the past 8 years. Major studies include:
  • 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)
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