Medical Device Safety Reporting and Solutions

Strategic foundation or review of your safety program with customized protocols and clear accountability frameworks.

• Custom creation and templates for internal and external safety communication
• Support for implementation and coordination
• Comprehensive safety protocols for each study activity
• Definition of roles and responsibilities for entire safety management process
• Organization of an efficient workflow

Serious Adverse Event (SAE) Collection and Reporting

Real-time adverse event processing with expert causality assessment and seamless regulatory reporting.

• SAE reporting, categorization, causality assessments and reconciliation
• Formation of E2B transport file for SAE integrations from the EDC system
• Safety database entry and CRF-compliant coding
• Signal detection and clinical case processing
• Comprehensive reporting including aggregate reports for devices, drugs and biologics.
• Literature screening and QPPV services with global PV audits

Safety Database Management

Robust, scalable database solutions with seamless integration and comprehensive data reconciliation.

• Safety database hosting and data maintenance
• Creation of safety database independent from the clinical trial database
• Custom database setup (Argus, ArisG, Safety Easy (AB Cube))
• Recording and organization of all data received by the safety department
• Reconciliation of safety data with clinical adverse event data
• Collaboration with the data management team