Our experienced CRAs support global and regional clinical trials through our comprehensive suite of clinical monitoring and site management services, from feasibility through to site closeout.
1. Feasibility Assessment
- Study feasibility assessment
- Country/Site recommendations
2. Site Identification and qualification
- Site assessment
- Review staff/investigator credentials
- Collate documentation
3. Investigator Site Set Up & Initiation
- Briefing/training of investigators, sub-investigators and staff
- Initiation in study procedures and documentation
4. Site Management
- Recruitment planning/tracking
- IMP Management
- Query resolution
5. Site Monitoring
- Review of source data, recruitment, informed consent, CRF, investigator site file
6. Site Closeout
- Ensure completeness of study documentation
- Closeout agreement and report