Best Practices for Sponsor RTSM Strategy Guidelines

This white paper presents a compilation of industry best practices for designing, implementing, and leveraging randomization and trial supply management (RTSM) software in clinical trials. It aims to provide general recommendations and discussion points for sponsor organizations, acknowledging the existence of internal standard operating procedures (SOPs) for clinical software. The document outlines the critical functions of RTSM systems, including drug dispensing and patient randomization, while addressing the complexities of modern clinical trials. It emphasizes the importance of establishing a clear RTSM strategy that encompasses quality and compliance, system design, user acceptance testing (UAT), and study close-out. Additionally, the paper discusses the necessity of integrating RTSM into the study planning process, designating internal subject matter experts, and ensuring proper vendor qualification. By following these best practices, organizations can enhance their RTSM processes and improve overall trial management efficiency.