QDRx - Safety Management (SM)
The QDRx SM product is a web-based clinical trial safety data and risk management collection system. In response to growing expectations from consumers regarding product safety, QDS offers a simple approach to housing and communicating this information effectively and in compliance with regulatory agency requirements. With QDRx SM, safety data is at your finger tips and is maintained in a tightly controlled, monitored database. Your data will be available for Safety Personnel to review at any time, world-wide. The system itself is role based and allows each client to customize their process flow whether you want the QDS Safety Team or your own to interact with sites and regulatory authorities for the collection and reporting of SAEs.
Features of SM:
- Real-time reporting
- Auto-generation of MedWatch and CIOMs Reports
- Concurrent encoding and reconciliation of SAEs with clinical database
- Dedicated FAX to PDF study-line providing e-mail, phone, and/or pager alerts to designated Study Team Members
- Creation of detailed, but easy to follow patient narratives
- Complete audit trail