Clinical Monitoring & Site Management
Our Clinical Research Associates (CRAs) are highly trained professionals who exercise ultimate efficiency in managing investigator sites. Lead CRAs are the primary point of contact between the CRAs and Project Manager (PM).
Our clinical monitoring and site management services include:
- Site identification and feasibility
- Review of inclusion exclusion criteria and the proper consenting of all subjects
- Site selection and qualification visits
- Assist with obtaining approval from local Ethics Committees and Institutional Review Board
- Managing subject recruitment
- Review of quality systems at the site and ensuring all sites are “audit ready”
- Initiation, interim monitoring, and study closure visits
- Essential document review, collection, and processing
- Good Clinical Practice monitoring, including motivational and training visits
- CAPA plan development and implementation
- Source documentation review, CRF review and query resolution
- Accountability for all study documents and materials
- Communication with sites
- Study specific training to site personnel
- Review of Investigational Product accountability and storage
- Review of safety information of all subjects
- Logging and correcting protocol deviations
- Monitoring study progress
- Mass mailings and newsletters to sites
- Database locks and study close out of sites
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