An Information System to Support and Monitor Clinical Trial Process

TL;DR

This paper presents MEDIS, an advanced information system designed to enhance transparency, collaboration, and monitoring of clinical trials, integrating HL7 standards for interoperability to improve efficiency and safety in medical research.

Contribution

The paper introduces MEDIS, a comprehensive clinical trial management system that extends traditional registries with new functionalities and HL7 v.3 standards for interoperability.

Findings

MEDIS supports tracking and monitoring of clinical trial processes.

The system facilitates information exchange between health information systems.

MEDIS improves transparency and collaboration in clinical research.

Abstract

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.