An Information System to support and monitor Clinical Trial process

The demand of transparency of clinical research results, the need of accelerating the process of transferring innovation in the daily medical practice as well as assuring patient safety and product efficacy make it necessary to extend the functionality of traditional trial registries. These new systems should combine different functionalities to track the information exchange, support collaborative work, manage regulatory documents and monitor the entire clinical investigation(CIV) lifecycle. This is the approach used to develop MEDIS, a Medical Device Information System, described in this paper under the perspective of the business process, and the underlining architecture. Moreover, MEDISwas designed on the basis of Health Level 7 (HL7) v.3 standards and methodologyto make it interoperable withsimilar registries, but also to facilitate information exchange between different health information systems.