- Study protocol and design
- Track and manage project timelines
- Budgeting services and tracking
- Coordination of resources and project staff
- Development of project specific study materials, documentation and newsletters
- Development of project specific Standard Operating Procedures
- Site and investigator selection
- National and international regulatory submissions, including ongoing correspondence and regulatory reporting requirements
- National and international Ethics Committee submissions including ongoing correspondence and reporting requirements
- Regulatory document review and collection
- Review and approval of Monitoring Reports
- Study specific reporting requirements
- Event management (Investigator meetings, update meetings and trial presentations)
- Archiving plans