Pharmacovigilance & Safety Services
Medicinal products receive regulatory approval if their therapeutic benefit proven in clinical trials outweighs the inherent risks of their application. The continuous monitoring of the benefit-risk-balance by sponsors of clinical trials and marketing authorization holders takes its start at the early phases of drug development and follows up after the market entry of a product throughout its entire life-cycle.
The subject of vigilance became increasingly important in the area of dietetics and food supplements throughout recent years not only in the framework of studies but also with regard to possible food-drug interactions. These products have therefore been integrated in our systems.
Adequate technical, organizational and personnel systems and targeted processes are key success factors for compliance with regulatory requirements and product safety.
We provide extensive expertise and offer comprehensive services covering a wide range of pharmacovigilance activities throughout the pre- and post-marketing period – all services are available as individual services or package solution:
- System Provision:
- QPPV function
- S2 PSMF usage or individual PSMF compilation and implementation
- Interventional Studies:
- AE/SAE management
- SUSAR reporting (E2B)
- DSUR preparation
- Non-interventional Studies:
- AE/SAE management
- ICSR reporting (E2B)
- Study report compilation
- Routine Activities:
- Risk management
- ICSR reporting (E2B)
- Signal management
- Literature monitoring
- PSUR preparation
- System Optimization:
- Optimization of existing processes and operating procedures
- Auditing / preparation for inspections
