Confidence offers medical monitoring services to provide medical oversight and support to the study sites and study team.
Confidence’s safety team works with the medical team to review and report adverse events to sites, ethics committees, institutional review boards, and competent authorities according to international and local regulations, and requirements.
Confidence’s Medical Monitoring and Safety Teams offer:
- Development of a Medical Monitoring Plan
- Development of a Safety Plan
- Hotline for the sites (24/7)
- Answering eligibility and medical questions
- Review of Adverse Events
- Review of Serious Adverse Events
- Review of Serious Adverse Device Effects
- Review of protocol deviations
- Participation in the DSMB meetings