Development and application of a digital intelligent platform for clinical trial management

This study leverages the existing hospital-based developed Clinical Trial Management System (CTMS) information management platform to create an integrated and targeted platform for the digital and intelligent management of clinical trials in response to emerging challenges. By overcoming barriers between clinical diagnosis and treatment data and the CTMS, this platform facilitates the seamless integration of clinical trial management data (such as project initiation applications, ethical reviews, protocol execution, subject visit management, investigational drug management, financial oversight, adverse reactions, and more.) with subject diagnosis and treatment data (such as Hospital Information System (HIS), Laboratory Information System (LIS), Picture Archiving and Communication System (PACS), and others). Adopting a problem-oriented approach to quality management, we developed a subject recruitment and screening system along with a remote monitoring subsystem. This initiative strengthens the role of the digital intelligent model in subject recruitment and remote monitoring. Additionally, research has been conducted on methods and technologies for segregating inpatient subjects' medical insurance expenses from clinical trial costs. We have established an independent comprehensive database for clinical trials, achieving closed-loop information management for clinical trials. The digital intelligent platform for clinical trials has undergone rigorous internal and external validation, and its application has been widely promoted, contributing to the high-quality development of new drug research and development in China.