Safety in a Box

Why Safety in a Box?

What do client get

Business Capabilities

Case Intake
  • Manual Intake (HQ, Local, Translation)
  • Automated Intake from eCRF or Similar Sources
  • External Access, Multi-Lingual, Auto-Triage etc.
Case Processing
  • Case Entry, QC, Medical Review & Submissions
  • Therapeutic Area Specialization
  • Local Country Submissions
  • Auto coding, PII, Always Serious Terms
Reporting
  • DSUR, PBRER, PADER, IND etc.
  • Self Service Ad-HOC Reporting
  • Report Listing Mailings (Internal, External)
  • Investigator Reporting
Oversight
  • Compliance Metrics
  • Productivity Metrics
  • Ease of Medical Review
  • Quality Metrics & Late Case Assessment
Signal & Risk Mgmt. (Optional)
  • Signal Tracking (GPV Module IX Compliance)
  • Signaling on FAERS, EVDAS, Clinical, Literature Data
  • Risk Management Plans, Commitments
Add-Ons (Optional)
  • EU QP PV Services
  • Local Country PV Operations e.g. Japan
  • Literature Intake
  • PSMF Management

IT Capabilities

Cloud (AWS Based)
  • Multi-Tenant (Dedicated Cloud Optional
  • Global Access including from Employee Home
  • 69 Availability Zones in 22 Global Regions
  • Hardware, Software, Network, Storage
System Security
  • Security Monitoring
  • Account, Access & Authorization
  • OS Hardening
  • Antivirus
  • Network Penetration Testing
Disaster Recovery
  • < 12 Hour RPO
  • < 24 Hour RTO
  • Annual Testing
Support Desk
  • 24 x 7 x 365
  • Named Client Support Manager
  • Expert System Engineers
Operational Support
  • Backup & Recovery
  • Capacity Planning
  • Application Updates
  • Tuning
Application Support
  • Break / Fix
  • Maintenance
  • Patching
  • DBA Services

Key Benefits

Flexibility & Scalability
  • Start small and scale up the "Box" as needed
  • Bring Safety in-house if needed
  • Option to have dedicated cloud
  • Compliance to changing Regulations
Control
  • Control on your own data. No dependency on IT or service provider for Medical Review, Reports etc.
  • Real time metrics on Compliance and Quality on your fingertips
  • Focus on your core business than talent acquisition, retention and systems
Costs
  • Predictable, fixed and all-inclusive annual fee
  • Competitive pricing
  • Multiple service provider options
  • Overall lower TCO - Expect to receive up to 30-50% savings