Discover Clynico’s comprehensive pharmacovigilance services, including Drug Safety Monitoring, Risk Management, Regulatory Support, ensuring patient safety and compliance with our expert solutions across Europe & North America
Pharmacovigilance System
- Pharmacovigilance System Master File (PSMF)
- Quality Management System (QMS)
- Standard Operating Procedure (SOP) Development
- System Benchmarking
- System Integration
ICSR Management
- Data Entry
- Case Intake and Triage
- Narrative Preparation
- Quality Control and Medical Review
- Reporting
Aggregate Safety Reports
- Periodic Safety Update Reports (PSUR)
- Post Authorization Safety Studies (PASS)
- Post Authorization Efficacy Studies (PAES)
- Benefit-risk Evaluation Reports (PBRER)
- Periodic Adverse Drug Experience Report (PADER)
- Development Safety Update Reports (DSUR)
Risk Management Plan
- Risk Management Planning
- Development and Implementation of Risk Minimization Measures
- Assessment of Risk Minimization Measures
- Risk Management Studies
Signal Detection
- Adverse Event Databases
- Active Surveillance
- Signal Detection Prioritization
Audit & Inspection Support
- Internal and Competent Authority Inspection and Audit Planning & Management
- GVP & QMS Auditing
- CAPA Development & Implementation
Other
- Medical Literature Monitoring and Medical Information
- Social Media Monitoring
- Interim Management
- Interim Staffing
- Staff Training
- Support drafting agreements i.e., SDEA and TA
- Medical Device Vigilance
- Cosmetovigilance
