Application of Project Information Management System in Non-Clinical Trials

This paper systematically summarizes the application status, achievements and challenges of Project Information Management System (PIMS) in non-clinical trials. By integrating the functions of experimental design, data collection, analysis and report generation, PIMS realizes the digital management of the whole process, significantly improves the efficiency and data quality, and supports the standardization of drug research and development and cross-departmental cooperation. Its four-tier technical architecture meets the requirements of GxP compliance, project management and data governance, which effectively reduces the error rate and shortens the approval period in practical application, and the return on investment reaches 55%. However, it still faces challenges such as poor system compatibility, great resistance to organizational change, insufficient intelligence level, complex transnational compliance and weak sustainability. Therefore, a number of coping strategies, including middleware development, edge computing, micro-service architecture, SaaS model, digital twinning, blockchain, differential privacy, etc., are proposed to provide theoretical support and practical paths for the informationization and intelligent transformation of pharmaceutical R&D.