Pharmacovigilance Services

Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis. Norwich pharmacovigilance is comprised of three units: drug safety and surveillance (DSS) for all drug products, risk management strategy (RMS) and regulatory affairs (RA).

The complete range of pharmacovigilance services includes:

• 24x7 call center equipped with Oracle AERS software
• Adverse event tracking
• Signal detection and trend analysis
• Literature reviews and medical narratives
• Preparation of ICSR and PSURs
• MedRA Coding
• Med Watch/CIOMS form generation
• Regulatory submissions

All of our Norwich pharmacovigilance services are conducted in strict conformity with GCP, GLP and CFR part 11 compliance.