Pharmacovigilance is a complex process for which robust systems are essential. A strong PV system is an important part of the overall regulatory system. It reflects on the stringency and competence of the regulatory bodies in regulating the market and ensuring the safety and effectiveness of the pharmaceutical products and devices.
Health and safety is our watchword. Our service of pharmacovigilance is top notch as we help clients around the world through improved clinical development.
Fully equipped, our goal is to see your business grow and expand as we guide you through every step of the PV process to meet your every need. PRA is global and our team is fully prepared to handle large case volumes. We are also dedicated to supporting our clients all through the product’s lifecycle. You can access our services on a standalone basis or in an integrated form through Medical Information and Regulatory Services.
Clinical Pharmacovigilance
We employ a robust professional staff of healthcare providers that work across a broad range of therapeutic areas. Our PV experts ensure safety and consistency throughout your clinical trials.
- Safety Management Plan (SMP) Development
- Clinical Pharmacovigilance (PV) Auditing Services
- Individual Case Safety Reports (ICSR) Processing and Submission
- Aggregate Safety Report Generation and Reporting
- Data Safety Monitoring Board
- Medical Monitoring