Our Clinical Trial experts are the backbone of every trial and manages all activities coordinated thorough study team meetings and communications, including study start-up activities, maintenance to study close-outs by utilizing our proprietary CTMS to report up-to-date study status, patient enrollment, site information and deadline and milestone tracking for regulatory documents and submissions.
CRAs will manage site visit objectives, including:
- Full SOPs (Standard Operating Procedures)
- Study & site startup activities
- Documents and Submissions
- IRB/EC meeting activity
- Contracts & budgets
- Screening and enrollment
- Study subject activity throughout the trial
- Regulatory documents (electronic and hard-copy)
- Monitoring visit Reports, calendars and schedules
- Safety Reporting
- Ensuring signed informed consent forms
- Source Data Verification (SDV), based on the protocol and study plans
- Reviewing all eCRF/CRFs and discuss trends with site staff
- Evaluating eCRF/CRFs for serious adverse events
- Performing drug accountability
- Reviewing investigator study files for completeness
- Ensuring protocol compliance
- Encouraging and supporting sites
