Feasibilities including assessment and qualification of sites
Initiation meetings including training of clinical study personnel
Monitoring:
- Initiation
- On-site monitoring
- Remote monitoring
- Co-monitoring
- Closure of sites
Quality assessment site visits
Project management:
- Management and training of study teams
- Planning, negotiation and overview of study budgets
- Recruitment
- Compliance with timelines
- Review of monitoring reports
- Quality assessment and assurance of monitors
Vendor management including quality assessment of vendors
Follow-up and control of CRO performance and results