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    • PvEdge – Safety Database
      • Post Marketing Safety (PMS) Reporting
      • Clinical ICSR
      • Medical Device Vigilance
      • Vaccine Vigilance
      • Case Routing Workflow
      • Oversight and Operational Efficiency
      • MedDRA auto-update
      • Periodic Listings and PADERs
      • Signal Detection
    • PvEdge – Multisource Inbox and Triage
      • PvD’Code – Structured Intake From Partners
      • PrITR – Unstructured Intake for PQC, MI and AE
      • LAM – Literature Intake Automation
    • PvEdge – Control Document Management System
      • Document Control
      • Report Compilation Automation
      • eCTD Publishing (PADER/PSUR)
    • PvEdge – Quality Management System
      • Quality Processes
      • Training Records
    • PvEdge – Gateway Connect
    • PvEdge – Academic Training
    • PvEdge – Veterinary Vigilance
  • Automations
    • Literature Automation Module
    • ICSR Submissions
    • Smart EV Triage
    • Automated Signal Detection
    • Document Automation
  • About Us
    • About Us
    • Blogs
  • Contact Us
  • Home
  • Solutions

    • PvEdge – Safety Database
      • Post Marketing Safety (PMS) Reporting
      • Clinical ICSR
      • Medical Device Vigilance
      • Vaccine Vigilance
      • Case Routing Workflow
      • Oversight and Operational Efficiency
      • MedDRA auto-update
      • Periodic Listings and PADERs
      • Signal Detection
    • PvEdge – Multisource Inbox and Triage
      • PvD’Code – Structured Intake From Partners
      • PrITR – Unstructured Intake for PQC, MI and AE
      • LAM – Literature Intake Automation
    • PvEdge – Control Document Management System
      • Document Control
      • Report Compilation Automation
      • eCTD Publishing (PADER/PSUR)
    • PvEdge – Quality Management System
      • Quality Processes
      • Training Records
    • PvEdge – Gateway Connect
    • PvEdge – Academic Training
    • PvEdge – Veterinary Vigilance
  • Automations

    • Literature Automation Module
    • ICSR Submissions
    • Smart EV Triage
    • Automated Signal Detection
    • Document Automation
  • About Us

    • About Us
    • Blogs
  • Contact Us
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Home
Solution
PvEdge – Safety Database
Post Marketing Safety (PMS) Reporting
Clinical ICSR
Medical Device Vigilance
Vaccine Vigilance
Case Routing Workflow
Oversight and Operational Efficiency
MedDRA Auto-update
Periodic Listings and PADERs
Signal Detection
PvEdge – Multisource Inbox And Triage
PvD’Code – Structured Intake From Partners
PRiTR – Unstructured Intake for PQC, MI and AE
LAM – Literature Intake Automation
PvEdge – CDMS
Document Control
Report Compilation Automation
eCTD Publishing
PvEdge Quality Management System
Quality Processes
Training Records
PvEdge – Veterinary Vigilance
PvEdge Gateway
PvEdge For Academic Training
Automations
Literature Automation Module
ICSR Submissions
Smart EV Triage
Automated Signal Detection
Document Automation
About US
About Us
Blogs
Contact us

 

PvEdge Outline

  • Solutions for different product categories in pharmacovigilance
  • Simple yet compliant Literature automation (LAM)
  • In-demand solution to deliver standard norms for product safety system in place
  • Facilitates day-to-day PV operations
  • Submissions feasible via Gateway connectivity

What’s New

  • MedDRA auto-update in cases
  • Automated PADER listings
  • Upcoming E2B (R3) safety database
  • Structured audit trail for tracing ICSRs across workflows and case versions
  • Generates bulk reports
  • ICSR submission eligibility identified for several countries
  • Multisource inbox for intake
  • EU Guidelines for Route of administration and Dosage form
  • Korean PV Submission
  • eCTD publishing and submission for PADER/PSUR
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