Pharmaceutical

Safety Surveillance

Wability understands that our clients have an enormous responsibility to ensure the safety of those who use their products. Our professionals have vast experience assisting clients with post marketing safety surveillance programs including:

• Designing and managing safety surveillance studies. Our clinicians bring years of experience in designing and managing safety surveillance programs. A dedicated Wability project team will work with you to develop an appropriate trial; one that will identify and quantify adverse event (AE) incidents rates, identify rate events, and describe the product safety profile.
  
  
• Spontaneous AE report collection, processing and regulatory reporting. Each program is customized and can include any or all of the following:
  • Receiving AE reports from healthcare professionals and from customers
  • Triaging calls such as product complaints back to the client side
  • Preparing data for inclusion in periodic safety updates
    
    
• Crisis Response/Crisis Management
  Our clinicians will work with you to prepare crisis management strategies. These strategies allow for rapid responses during periods of AE reporting or product withdrawal.
  
  Our activities range from preparation of standard responses to health care professionals and consumers to proactive epidemiological evaluation.
  
  
• On-site safety surveillance support
  Wability provides medically qualified staff directly to clients to assist in safety surveillance efforts. Our expertise lends itself to:
  • Providing medical reviews and the processing of expedited FDA 3500A and CIOMS I reports
  • Reviewing legal briefs to identify potential serious events
  • Addressing incoming telephone calls from health care professionals and consumers
    
    
• Epidemiological Analysis
  The epidemiological components of a surveillance program include:
  • The development of strategies for signal detection
  • Analysis of external data sources
  • The creation of registries for continuous safety monitoring of one or more of your products

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