Pharmacovigilance
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 our deep expertise in ICSR processing, aggregate reporting, signal and risk management, and regulatory compliance, we are well-equipped to assist you.
Our services include:
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
Risk Management Plan/Risk Evaluation and Mitigation Strategy
Pharmacovigilance System Master File (PSMF)
Qualified Person for Pharmacovigilance (QPPV)
Pharmacovigilance Inspections and Audits
