Service

Pharmacovigilance

Pharmacovigilance Process

We provide comprehensive, high-quality, and cost-effective solutions to address challenges in clinical safety and post-market surveillance. Our services are tailored to fit your budget and organizational culture, ensuring patient safety remains a top priority. With deep expertise in ICSR processing, aggregate reporting, signal and risk management, and regulatory compliance, we are well-equipped to assist you.

End-to-End Individual Case Safety Report (ICSR) Processing

  • SAE/AE Reporting: Clinical Trial and Post-Market Surveillance
  • Expedited reporting
  • Medical review

Aggregate Safety Reporting

  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit Risk Evaluation Reports (PBRERs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Integrated Summaries of Efficacy (ISE) and Safety (ISS) for the US
  • Clinical Summaries of Safety (EU)
  • Addendum to Clinical Overview (ADCO)
  • Annual Safety Report (ASR)
  • Annual Investigational New Drug (IND) Safety Report

Literature Monitoring

  • Global Literature Screening
  • Local Literature Screening as per Local Regulations
  • End-to-End Literature Search and Review
  • Medical Literature Monitoring

Signal Management

  • Signal Detection
  • Signal Validation
  • Signal Confirmation
  • Signal Analysis and Prioritization
  • Signal Assessment and Recommendation for Action

Additional PV Services

  • Risk Management Plan / Risk Evaluation and Mitigation Strategy
  • Pharmacovigilance System Master File (PSMF)
  • Qualified Person for Pharmacovigilance (QPPV)
  • Pharmacovigilance Inspections and Audits