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