Services

Closely working with sponsors and CRO (Clinical Research Organizations), UREAD provides:

  • Assistance in study design
  • Development of imaging acquisition protocols
  • Guidance, support, and certification of imaging systems and imaging technicians/photographers
  • Technical monitoring of imaging data acquisition within clinical studies including query management, quality control, and quality assurance
  • Systematic and standardized analysis (“Grading”) of imaging data and functional test data according to pre-defined standard operational procedures by highly trained readers
  • Sophisticated automated algorithms for evaluation of retinal imaging data using machine-learning approaches 

Quality Assurance and Regulatory Compliance

  • SOPs
  • Fully trained, professional readers
  • Constant Inter- and intra-reader validation
  • Double read models and arbitration procedures
  • Trained on HIPAA and human subject research regulations
  • Adherence to ICH guidelines and FDA regulations

Imaging modalities and functional tests

  • Fundus camera photography
  • Fundus autofluorescence and reflectance imaging
  • Optical coherence tomography
  • Optical coherence tomography angiography
  • Fluorescein angiography
  • Indocyanine green angiography
  • Fundus-controlled (so-called microperimetry)
  • Dark adaptometry