Clinical and Functional Services
Clinical Operations and Study Monitoring
Study Protocol Design
Pre-study planning
Site Management (Site Selection and study initiation)
Study conduct and site monitoring
Study Closeout
Resource Management
Study Data Management Planning
Study Database setup (EDC and Manual)
Data Validation and Quality Management
Data extraction and Locking
Regulatory
The Pharmacovigilance system master file (PSMF) for European agencies
Patient safety monitoring and AE reporting
Drug safety and PV
Life Cycle Safety and Management