PHARMACOVIGILANCE/DRUG SAFETY

 

Argaav offers a comprehensive range of PV services throughout entire product life-cycle. Argaav PV team is your reliable partner in reaching maximal effectiveness of your pharmacovigilance system and complex regulatory requirements

  • Individual case safety Reporting (Drugs & Devices)
  • Literature screening
  • MedDRA coding
  • Aggregate Reporting

Development Safety Update Report (DSUR)
PSUR/PBRER
PADER

  • Benefit Risk Assessment
  • RMP
  • Risk Evaluation and Mitigation Strategies
  • Data Mining
  • Reconciliation of Serious Adverse Events between the clinical and safety database
  • Training / briefing (in-house and investigators)
  • Medical information call centre setup
  • Study documentation review and update, including protocol and Investigator’s Brochure
  • Signal detection and Ad hoc safety analyses
  • Audit and Inspection support
  • Developing SOPs based on good pharmacovigilance practices
  • Setting up of comprehensive pharmacovigilance system
  • EU QPPV and Local Responsible Services.

Other services:

Integrated Medical Inquiry Platform
PSUR/PBRER Line Listings
Database migration
Interactive Web Responsive System

 

 

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