Construction and practice of early clinical research management system based on SaaS / 中华医院管理杂志

ABSTRACT

The " Internet plus" development approach for early phase clinical study management is of great significance to improve the implementation quality and management effectiveness of clinical trials. In December 2020, a tertiary hospital used the internet platform SaaS mode to build its early clinical study management system, with the design concepts of simplicity, convenience and adaptability. Based on cloud computing and multi-level data flow mode, the system formed a simple and feasible system architecture, real-time follow-up system process and dynamic visual project information through the adaptive design of mobile terminal application link and system user interface, with the advantages of low cost, high flexibility, strong specificity and multi-party interoperability.Since its launched in January 2021, as of May 2022, the system had included 56 early clinical trial projects of the hospital, effectively improving the implementation progress and quality of early clinical trials, strengthening the risk control in the trial, so as to provide reference for the digital development of hospital clinical research.