Site Monitoring
CLINICAL MONITORING & SITE MANAGEMENT
Our Clinical Research Associates (CRAs) are highly trained professionals who exercise ultimate efficiency in managing investigator sites and providing clinical trial monitoring services.
Our clinical monitoring and site management services include:
- Site identification and feasibility
- Site selection and qualification visits
- Assist with obtaining approval from local Ethics Committees and Institutional Review Boards
- Ensuring Rights, Safety and wellbeing
- Ensuring Safety Reporting, CIOMS/INDSR
- Communication with the site and sponsor, Reporting to sponsor via visit report, escalation of issues, detection of issue, fraud or misconduct
- Managing subject recruitment
- Review of inclusion exclusion criteria and the proper consenting of all subjects
- Review of quality systems at the site and ensuring all sites are audit ready
- Initiation, interim monitoring, and study closure visits
- Essential document collection, review and processing
- Following Good Clinical Practices in monitoring
- Conducting motivational and training visits
- 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 given to all subjects
- Logging and notify protocol deviations
- Monitoring study progress
- Database lock and study close out
- Mass mailings and newsletters to sites
- Archival of study documents at site