Product/Service


Clinical Service - Pharmacovigilance

Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.

Details

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.

Learn more about Norwich Clinical Services


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Norwich Pharmaceuticals

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