Our team of experts delivers unrivalled quality in pharmacovigilance case processing, offering flexible hosting options to meet global sponsor needs. PrimeVigilance provides comprehensive support in ICSR case processing, including collection, data entry, MedDRA coding, narrative writing, medical assessment, and expedited reporting.
Expertise in PV Case Processing
With decades of experience, our PV case processing teams manage high volumes of safety data with precision and compliance. We process over 350,000 initial and follow-up cases each year, achieving a >99% on-time completion compliance rate.
Our services include:
- ICSR case management with or without medical review
- Drug safety case processing for both clinical trial and post-marketing reports
- SUSAR reporting and expedited submissions
- Safety narrative writing tailored to regulatory requirements
Managing Complex Clinical Trial Safety
With caseloads increasing by 30–50% annually and evolving regulations, efficient clinical trial case processing is critical for compliance and patient safety. PrimeVigilance offers scalable case processing pharmacovigilance solutions that ensure business continuity, regulatory compliance, and operational efficiency.
- 97% of clinical cases completed within 5 follow-up attempts
- 89% of cases closed within 3 follow-up attempts
- Proven compliance with global safety regulations
Technology-Driven Efficiency
PrimeVigilance’s advanced SAE Management System reduces burdens for investigators by streamlining intake from multiple sources (EDC, paper, gateway). This ensures consistency across geographies and programs while addressing the complexity of modern drug safety case processing.
