We provide exceptional prowess at each stage of incident reporting management:
- Intake
- Triage
- Data Entry
- Quality Review
- Medical Review
- Submissions
The modular design of our offerings allows the selection of individual services or an end-to-end solution for adverse incident reporting and management in the early clinical trial phases to post-marketing surveillance.
Our specialists have proficiency in Argus, ARISg/LifeSphere Safety, and other safety databases. We enhance our medical device incident reporting management capabilities by providing the following services:
- Medical Device Call Center (MDCC) Management for Follow Up
- Automated Tracking of Open and Missing Incidents
- Monitoring of Expedited Reporting and Reporting of Submission Status
- Submission of Serious Adverse Incident Reports to Health Authorities
- Quality Assurance