Comprehensive Safety Surveillance Across the Product Lifecycle
Clinovalife delivers end-to-end Pharmacovigilance (PV) services designed to ensure proactive safety monitoring, regulatory compliance, and risk mitigation across clinical and post-authorization phases. Our services align with ICH guidelines, FDA, EMA, MHRA, and other global regulatory authorities.
Case Processing & Individual Case Safety Reports (ICSRs)
Safety Case Intake & Triage
- SAE intake and documentation
- Case validation and data entry
- Medical review coordination
- Follow-up management
Case Processing
- ICSR processing (clinical and post-marketing)
- MedDRA coding
- Causality assessment support
- Expedited reporting (SUSAR reporting)
Regulatory Reporting
- Submission to regulatory authorities
- Compliance with reporting timelines
- E2B electronic submissions
- Local regulatory reporting coordination
Aggregate Safety Reporting
- Development Safety Update Reports (DSUR)
- Periodic Safety Update Reports (PSUR)
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Annual safety reports
- Signal evaluation summaries
- Safety trend analysis
Signal Detection & Risk Management
- Quantitative signal detection analysis
- Disproportionality analysis
- Data mining techniques
- Trend evaluation
- Risk Management Plan (RMP) development
- Risk minimization strategies
- Benefit-risk assessment documentation
- Post-authorization safety study (PASS) support
Safety Database & Systems Management
- Safety database configuration and management
- Data reconciliation with Clinical Data Management
- System validation support
- Workflow automation
- 21 CFR Part 11 compliance support
QPPV & Regulatory Compliance Support
- Qualified Person for Pharmacovigilance (QPPV) support
- Pharmacovigilance System Master File (PSMF) maintenance
- PV audits and inspection support
- Corrective and Preventive Action (CAPA) management
- Regulatory intelligence and updates
Clinical Trial Safety Oversight
- Safety data reconciliation (SAE reconciliation)
- Data Monitoring Committee (DMC) safety support
- SUSAR reporting
- Safety review meetings
- Blinded and unblinded safety analysis coordination
Why Sponsors Partner With Us
- Experienced safety physicians and PV specialists
- Strong global regulatory understanding
- Robust quality and governance framework
- Integrated biometrics and regulatory expertise
- Transparent reporting and compliance oversight