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