EPV Services
Process & Improvement
Process & Improvement
Process & Improvement
- Safety & PV SOPs, Policy, & WI Generation & Review
- PSMF Support, Templates,
- PV System Gap Analysis
- Organizational Structure Support (JDs, functional development)
- SAERF & Pregnancy Report Form Templates
- PV Agreements / SDEAs
- Protocol & IB Review
- Clinical Safety & PV SOPs, Policy, & WI Generation & Review
- PSMF & RMP Implementation, Support, Templates, Gap Analysis
- Organizational Structure Support (Job descriptions, functional development)
- SAERF & Pregnancy Report Form Templates
- PV Agreements
- Protocol & IB Review
- REMS Implementation and Audits
- Signal Detection & Risk Management
- Case processing & Medical review
- Aggregate Safety Reports Generation & Review (PADER, PBRER, PSUR, DSUR, etc.)
- GVP Audits and Risked Based Audit Strategy Approach
- GVP Vendor Selection, Management, and Support
- GVP Regulatory Review & Information
- GVP Inspection Readiness and execution
Training
Process & Improvement
Process & Improvement
Assistance with the review and development of:
- General and/or product specific Safety/AE training
- PV curriculum review & development for Safety & PV Professionals
Topic Specific & Tailored Training - In person or Remote
- PSMF Management
- Developing a compliant PV Quality Management System
- GVP Training
- ICSR & Safety Narrative writing
- QC Principles & Practices
- Generating and Tracking Safety Letters & Effective communication
Quality & Compliance
Quality & Compliance
Quality & Compliance
- Auditing support, audit report & CAPA Plan templates and management
- PV Inspection Readiness & Training, Front & Backroom support and management
- GVP Annual and Strategic Plans with Risk-based Assessment strategies
- Compliance Metrics & strategies
Quality & Compliance
Quality & Compliance
