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. Auditing

  • CQA Site audits are delivered by our CQA team

7. Site Closeout

  • Ensure completeness of study documentation
  • Closeout agreement and report