We believe that risk-based monitoring improves sponsor supervision of clinical investigations. As clinical research data becomes increasingly digitized and as data standardization is achieved, a transition to centralized, analytics-enabled monitoring will become a reality. Early detection of issues can mitigate risks or prevent them entirely, through remote monitoring.
Although there will continue to be some on-site monitoring in the future, we expect this to slowly decline because of the evolution of technology in the remote monitoring process.
OUR TRIAL MONITORING ACTIVITIES INCLUDE:
- Full service monitor visits – qualification, initiation, routine, and close-out
- Comprehensive monitor plans
- Thorough review of site records
- Timely completion of visit reports
- Quality review of monitor reports
- Source document verification as per monitor plans
- Rapid query resolution
- Site training and support
- Site management support & documentation
- Periodic remote EDC review
- Drug accountability