Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite

  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite 1
  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite 2
  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite 3
Product Description

AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting.

  • Case Intake
  • Case Processing
  • Case Submission
  • Risk Management Plans
  • Signal Detection
  • CDMS
  • CAPA
  • Document Control and Issuance
  • Training Management


Automations: Triaging | Data Mining | Reporting

Case Intake
Collects data from the literature, regulatory, MICC, Licensing Partner, Clinical Trial and Web Portals

Case Processing
Automates MedDRA updates, patient narratives, causality assessment, XML validation and quality checks

Regulatory Submission
Supports global formats (R2/R3 XML, CIOMS, MedWatch) with a secure AS2 gateway for FDA, MHRA, PMDA, TGA, KFDA, Health Canada, EMA and others.

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Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology
View company profile
Categories
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Specifications
  • Details
    500K+ cases migrated, 5 Mn+ case processed, 3500+ Users, 100+ Successful Audits, 250+ MAH’s Served
  • Model
    Pre-Validated, Cloud Ready, Globally Compliant, Implementation under 2 weeks, Data Migration Expertise
  • Supplied from
    India
More specifications Fewer specifications
Sales Markets
Show more Show less

Sarjen Systems Private Limited

  • IN
  • 2019
    On CPHI since
  • 1
    Certificates
  • 250 - 499
    Employees
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology
View company profile

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