Allied Safety Activities
Allied Safety Activities are a crucial component of a company’s comprehensive pharmacovigilance approach to ensure drug safety and efficacy. Artixio’s allied safety activities encompass a wide range of services beyond traditional adverse event monitoring including risk management planning, safety data exchange agreements, literature surveillance, and the development of Risk Evaluation and others to ensure our clients meet their product safety business objectives.
Allied Safety Activities
Audit & Inspection
Support
Audit readiness
Compliance monitoring
Periodic checks
Inspection support
CAPA management
Safety Data Exchange Agreement
Draft & Review the SDEA
Data collection & coordination
SDEA schedule & maintenance
SDEA renewal
SDEA archival
QPPV Office
EU-QPPV support
EA EU QPPV support
LPPV/LPVRP support
SPSMF management
Eudravigilance support
Affiliate Support
Local point of contact for country support
Local case intake & processing
Local HA communications & coordination
Handling of local PV activities
Technology Services
Safety database hosting & implementation
Validation support
Automation tool development