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