Site Management Services
- Study Feasibility Assessment
- Selection of Investigators
- Site contracting
- Preparing site-specific documentation for EC submissions
- Patient screening
- Patient enrolment
- Informed consent
- Patient follow-up
- Participation in site initiation and study close-out
- Data collection and data entry
- Maintenance of site files
- Participation in management of safety events
- Ensuring protocol compliance
- Advising & alerting investigators of potential protocol violations
- Advising & alerting investigators of potential ICH-GCP/ISO violations
- Participation in site audits and inspections