Independent Review

The independent blinded read is the crucial step to which everything is focused. Our read management team handles all aspects of the read in accordance with the Independent Review Charter. Leading experts with therapeutic-area expertise in specific modalities, sub-specialties, and disease specifications are assembled and assigned to your team. This team designs and develops the read methodology and — depending on the nature of your study — initiates their methodology prior to patient enrollment or in conjunction with the receipt and on-going quality control of the image data.

This process includes but is not limited to the following:

  • Analyze images
  • Design independent read system
  • Develop Imaging Review Charter
  • Provide reader training
  • Conduct independent read
  • Monitor independent read
  • Monitor inter/intra reader variability
  • Export data

 

Independent Review Expertise

The independent blinded interpretation of the imaging data is of paramount importance in every clinical trial. BioClinica’s BioREAD system provides the platform for state-of-the-art radiological evaluation of the clinical trial data. The BioREAD system allows the images to be displayed in a completely blinded fashion, eliminating potential bias associated with the review. The radiologists selected for these reads are all licensed, board-certified experts — many of whom hold fellowship training in their respective therapeutic area and meet all FDA requirements as independent consultant readers. We select a minimum of two experienced independent readers from different institutions. The radiologists are selected either by the client or from BioClinica’s extensive network or radiologists. Curricula vitae are available for client review and approval prior to the final selection of readers.