An Information System to Support and Monitor Clinical Trial Process

The demand of transparency of clinical research results, the need of accelerating the process oftransferring innovation in the daily medical practice as well as assuring patient safety and product efficacymake it necessary to extend the functionality of traditional trial registries. These new systems shouldcombine different functionalities to track the information exchange, support collaborative work, manageregulatory documents and monitor the entire clinical investigation (CIV) lifecycle. This is the approachused to develop MEDIS, a Medical Device Information System, described in this paper under theperspective of the business process, and the underlining architecture. Moreover, MEDIS was designed onthe basis of Health Level 7 (HL7) v.3 standards and methodology to make it interoperable with similarregistries, but also to facilitate information exchange between different health information systems.