Pharmacovigilance
4C Pharma Solutions

ONGOING SUPPORT

  • Safety Development Plan – SOP writing, Data Migration, Implementation, Training
  • Case intake and Monitoring - Call centre activities for AEs, PQCs and MI, Validity, Duplicate check, Reportability, Triage
  • AE/ SAE/ processing – Data Entry, Coding, Narrative Writing, Validation, Medical Review, Submission, Follow-up, Compliance
  • Literature Search & Insights
4C Pharma Solutions

PRE-DEFINED SUPPORT

  • Aggregate Reports – DSURs, PSURs, PADERs, PBRERs
  • Signal detection, prioritization, evaluation
  • Risk Management Plans (RMPs), REMS
  • Social Media Analytics for PMS and Spontaneous Adverse Events
4C Pharma Solutions

ADHOC SUPPORT

  • Medical Monitoring
  • Risk-Benefit Assessment
  • Regulatory Authority Requests, Audit/ Inspection readiness, mock-audits
  • Health Care Analytics
  • Research Analytics and Insights

Pharmacovigilance Spectrum

4C Pharma Solutions-pharmavigilance
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