• CDISC compliant database allowing the data to be shared directly with the FDA for analyses around safety and efficacy as part of a formal MOU (#225-13-0012) executed in 2013.
  • HCV-TARGET developed standardized, centralized chart data abstraction methods along data monitoring to increase the efficiency and quality of an observational registry while also minimizing costs typically associated with performing post-marketing clinical research.
  • HCV-TARGET hosts REDCap databases that are CFR 21 Part 11 compliant and includes MEDRA adverse event and WHO drug dictionary coding standardization.