PvEdge - Drug Safety Database and Pharmacovigilance Automation

Product Description

PvEdge 360* End-To-End safety database provides comprehensive analyses of adverse events arising from the use of pharmaceutical products (Drug, Medical Device or Therapy, Vaccine). It is an advanced Pharmacovigilance solution that helps combat the complexity of the safety data and comprehensively caters to all risk management requirements on a single platform, ensuring global regulatory compliance.

PvEdge Capabilities

·   Korean PV case submission

·    Multi-vigilance & multi-client safety database

·    Interactive dashboards, noti­fications & reports supporting case/individual quality metrics & informed decision making

·   Supports multilingual report narratives & eCTD publishing and submission (PSURs/PADERs)

·   Support standard dictionaries (MedDRA, WHO-DD, FDA-Device/Patient problem code)

 PvEdge regulatory compliant deliverance

·   Ensure adherence to GvP, GDPR & HIPPA

·   Guidelines for drug, device, vaccine and combinational product vigilance

·    ICH E2B PV guidelines

·    Part 11 compliance (21 CFR part 11 and Annex 11)

·    CDSCO adherence as per PVPI and SAEs management for IRB/IECs

·     Region-wise guideline implementation for submission as per standard norms

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Pharmaceutical company
Primary activities
Regulatory Affairs
Technology
Specifications
  • Model
    Pharmacovigilance - Drug, Device, Vaccine and Combination Product, SD, Automated Literature, ICSR GATEWAY Connect eCTD publishing (PADER/PSUR), PV QMS, SDEA, Multisource Inbox and Triage
  • Supplied from
    India

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
IT/Software solution provider
Pharmaceutical company
Primary activities
Regulatory Affairs
Technology

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