Clinical Monitoring - RBM: Risk-Based Monitoring, CM: Centralized Monitoring, RM: Remote Monitoring, Adaptive

• Feasibility & Site Identification
• Site Qualification and Initiation
• Collection & preparation of regulatory documents
• Budget and contract negotiation
• Site Recruitment strategy
• Site personnel training
• Interim site monitoring
• Initiation and management of CAPA
• Accountability investigational material(s)
• Study closure
• Site Management