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RANGE OF SERVICES

The range of services that Vigi Medsafe can offer are vast. The list mentioned will continue to expand as the company keeps getting stronger and stronger. With a number of SOPs in place defining each and every function of the company, databases that are world renowned and market leaders, and the IT framework that can support any need, Vigi Medsafe is for sure will address the need as it arises.

  • Protocol writing and review
  • Study configuration
  • Clinical trial case processing
  • Investigator’s brochure update
  • Investigator Notification preparation
  • Unblinding of cases
  • Data reconciliation between the clinical and safety database
  • Development Safety Update Report
  • Medical information call-center setup
  • End to end case processing
  • Aggregate report authoring/review (PSURs, PBRERs, PADERs, ASRs)
  • EU and local QPPV services
  • Pharmacovigilance System Master File
  • Developing SOPs based on good pharmacovigilance practices
  • Setting up of comprehensive pharmacovigilance system
  • Risk Management Plans authoring / updates
  • Risk Evaluation and Mitigation Strategies
  • Literature screening and review
  • Signal management
  • Company core data sheet update
  • SmPC update for generic molecules
  • Preparation of Health authority responses as required
  • Multi-lingual dossier translation
  • Tailored corporate training on pharmacovigilance
  • Medical Impact Analysis
  • Data Management
  • Consulting for database migration
  • Submission of ICSRs through direct gateway to the concerned health authority
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