An Information System to Support and Monitor Clinical Trial Process
This work addresses the problem of improving clinical trial management and information exchange for researchers and healthcare professionals, but it appears incremental as it extends existing trial registry functionalities.
The paper tackles the need for enhanced clinical trial transparency and efficiency by developing MEDIS, a Medical Device Information System that integrates multiple functionalities to support and monitor the entire clinical investigation lifecycle, based on HL7 v.3 standards for interoperability.
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, MEDIS was designed on the basis of Health Level 7 (HL7) v.3 standards and methodology to make it interoperable with similar registries, but also to facilitate information exchange between different health information systems.