Clinical Monitoring – Site Management

CRCN Network professionals covers phase I-IV Clinical Research Trials Onsite Monitoring and is experienced with Risk-Based Monitoring. Full Monitoring and Site Management Service includes the following activities:

  • Site identification and feasibility
  • Site selection and qualification visits
  • Communication with sites
  • Initiation, interim monitoring, and study closure visits
  • Essential document collection, review and processing
  • Managing subject recruitment
  • Review of quality systems at the site and ensuring all sites are audit ready
  • GCP Monitoring, including motivational and training visits
  • CAPA plan development and implementation
  • Source documentation review, CRF review and query resolution
  • Review of inclusion exclusion criteria and the proper consenting of all subjects
  • Review of Investigational Product accountability and storage
  • Study specific training to site personnel
  • Review of safety information of all subjects
  • Logging and correcting protocol deviations
  • Study close out
  • Mailings and newsletters to sites