SAFETY SERVICES / 03
Individual Case Safety Reports & Safety Operations
Define reliable case workflows, from intake and medical coding to quality review and reporting support.
Discuss this service
What this service covers
- ICSR intake and processing
- Case assessment and quality review
- MedDRA coding support
- Expedited safety reporting support
- Literature surveillance
- Safety reconciliation
- Safety database operations through qualified providers
Potential deliverables
- Case processing conventions and workflow
- Reconciliation and quality review plan
- Reporting responsibilities and operational metrics
What to bring to the discussion
- Products, countries and expected case volumes
- Source systems and database arrangements
- Reporting pathways, handovers and coverage needs
Qualified specialists, delivery arrangements and responsibilities are agreed before contracting.
WHAT WE CAN SUPPORT
Expertise for your scope.
- ICSR intake and processing
- Case assessment and quality review
- MedDRA coding support
- Expedited safety reporting support
- Literature surveillance
- Safety reconciliation
- Safety database operations through qualified providers
Potential deliverables
- Case processing conventions and workflow
- Reconciliation and quality review plan
- Reporting responsibilities and operational metrics
Start with your context
- Products, countries and expected case volumes
- Source systems and database arrangements
- Reporting pathways, handovers and coverage needs