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Pharmacovigilance

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With our highly experienced and committed pharmacovigilance team, “PV-Arena” database, and tailored pharmacovigilance solutions, we support our customers with the needed specialized patient safety and regulatory affairs services for all related pharmacovigilance activities.

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Services

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Our safety reporting management system “PV-Arena” is designed to be a reliable tool with the following features:

  • [medin_icon icon=”icon-check-mark-1″]ICH E2B (R2) Reporting Support
  • [medin_icon icon=”icon-check-mark-1″]MedDRA Browser Integration
  • [medin_icon icon=”icon-check-mark-1″]XML Case Reporting
  • [medin_icon icon=”icon-check-mark-1″]Signal Detection
  • [medin_icon icon=”icon-check-mark-1″]Duplicate Check
  • [medin_icon icon=”icon-check-mark-1″]Full Audit Trail
  • [medin_icon icon=”icon-check-mark-1″]Integrated Document Management

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Full Delegation or on-demand “Qualified Person of Pharmacovigilance (QPPV)/ Local Safety Reporter (LSR)”:

  • [medin_icon icon=”icon-check-mark-1″]Risk Management Plans (RMP)
  • [medin_icon icon=”icon-check-mark-1″]Pharmacovigilance System Master File (PSMF)
  • [medin_icon icon=”icon-check-mark-1″]Processing Individual Case Safety Report (ICSR)

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  • [medin_icon icon=”icon-check-mark-1″]Ad-Hoc analysis
  • [medin_icon icon=”icon-check-mark-1″]Periodic Benefit-Risk Evaluation Reports (PBRER)

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