Safety is paramount during all phases of clinical research.
We can provide the following medical monitoring services:
- Medical support to sites for study protocol interpretation and subject medical management
- Medical review and assessment of serious adverse event reports
- Preparation of serious adverse event narratives for regulatory reporting or inclusion in clinical study reports
- Assistance with, and participation in, Data Safety Monitoring Boards
- Timely receipt, processing and communication of initial serious adverse event reports and follow-up to case closure
- Safety reporting in compliance with local regulatory requirements
- Preparation and distribution of investigator notification letters.