Project Management Services:
- Preparation and coordination of all trial-related documentation
- Supervising of all trial-related procedures
- Securing timelines with all cooperation partners
- Coordination of Clinical Trial Submissions at Ethics Commitees and Regulatory Authorities
- Obtaining regulatory submissions
- Preparation of monitoring plans, overviewing monitoring activities and reporting
- Organization and supervision of all trial-related logistical processes including sample shipments
- Provision Project Status Reports
- Investigator Meeting organization
Site Management Services:
- Interaction with clinical sites and investigators
- Tight communication and reporting to central project management team at headquarters
- Organization of local team meetings
- Investigators and site fee negotiation
- Investigators and sites contract management and finalization
- Administrative payments to investigators and sites