SAFETY AND PHARMACOVIGILANCE SOLUTIONS
Patient safety first
When it comes to patient safety and clinical trial pharmacovigilance, Biorasi is with you every step of the way.
Dipali Patel, VP, Medical and Scientific Affairs
Biorasi knows that patient safety comes first across all stages of clinical research, from innovation and discovery to clinical trials and clinical practice. Our Safety and Pharmacovigilance team provides end-to-end safety activities designed to meet your study goals for patient care and regulatory compliance.
Comprehensive safety strategies
Pre-Marketing/Phase I to III: What are your safety data goals? Biorasi leverages over 20 years of experience in Safety and Pharmacovigilance to give your clinical trials an edge right from the beginning.
Real-world data capture
Post-Marketing/Phase IV+: Our Safety and Pharmacovigilance expertise doesn’t end outside of the clinical trial setting. Biorasi offers a broad range of post-marketing and surveillance solutions for Phase IV trials and beyond.
Audit-ready for the world
Standalone & Mock Audits: Biorasi works with you every step of the way throughout your clinical trial. We offer standalone audit services to ensure your team is ready for regulatory compliance and approval. Plus, we can provide mock audit activities to bring your data and reporting in line for upcoming regulatory reviews.
The Qualified GVP Auditors at Biorasi can support pharmacovigilance inspection readiness through:
- Full System Audit
- Distributor / Business Partner Audit
- QPPV Audit
- Affiliate Audit
- PSMF Audit
- Gap Assessment