While a company’s goal is to move a drug through all phases of development in a timely and cost-efficient manner, the obligation to protect public safety remains paramount. Adequate monitoring and assessment of drug/vaccine safety during development and product lifecycle is a vital concern of both industry and regulatory authorities. These include the following activities, which are all supported by P95:

  • Benefit-risk assessment
  • Individual Adverse Event management 
  • Aggregate case reviews
  • Periodic Safety Reports 
  • Signal detection and evaluation
  • Risk management plans and risk evaluation and mitigation strategy
  • Process development
  • QPPV services
  • Training
  • DSMB or IDMC support


DRIVE: A call for tenders

Measuring brand-specific influenza vaccine effectiveness in EU/EEA: a call for tenders

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New publication

P95 co-authored paper on Norovirus disease in Japan featured in PLoS Disease Forecasting & Surveillance ...
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New publication

Paper of P95 co-authors has been published online

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