Drug Safety

The Drug Safety process requires pharmaceutical companies to demonstrate a rigorous and ongoing safety surveillance program to support quick action and response on any safety concerns. Recommended actions for each drug can vary further for each type of safety issue depending on the patient data. Failure to respond to safety signals in a timely manner with the most informed response (that has input from all SME’s) can negatively impact the brand, reputation, patient trust and result in penalties.

Most pharmaceutical companies manage this process today with a combination of a legacy Drug Safety application (often aging and rigid) complimented with MS Office, SharePoint and emails. This approach does not provide a structured workflow to ensure efficient collaboration amongst SME’s to prepare the most accurate and timely response to safety signals.

Pain Points of traditional approach to Drug Safety include:

  • Off-the-shelf solutions have rigid workflow (if at all)
  • Lack of automated workflow requires human governance
  • Emails, MS Office and SharePoint are used for collaboration

Responding to drug safety signals requires a coordinated collaboration of various SMEs to ensure the best response goes out within a very short timeframe. The approach should be consistent yet flexible enough to adapt to each safety issue uniquely. The Princeton Blue Drug Safety solution uses a paradigm called Dynamic Case Management (DCM) which allows the drug safety team to define workflows for each drug or therapeutic area during initial setup, and tailor the process for each signal as it comes in. DCM provides a flexible mechanism to dynamically configure the most effective activities for signal analysis and prioritization. Appian Low-code Process Automation technology allows us to build this Drug Safety solution fully integrated with your legacy applications in weeks rather than months. Key features of this rich, mobile-enabled solution include:

  • Configurable Workflows
    • Dynamic workflows can be customized for each drug or therapeutic area and further tailored for each signal based on patient data. This results in the most inclusive, efficient and timely response to the safety signal
  • Signal Response Status
    • The process creates tasks and assigns them to the right individuals and ensures that they get it done in a timely manner. Unified transparency into signal processing status and progression shows team’s performance and areas that need attention.
  • Collaboration
    • Real-time collaboration on case data, findings, and outcomes ensures everyone has access to the latest information in one place. Process based collaboration provides an audit trail of who contributed what and when. Proactive alerts ensure a timely response from everyone.
  • Interactive Dashboards
    • Role-based dashboard and reports provide insights for each safety signal, its status, pace of progression and response readiness. Pick up early signs of process friction and bottlenecks so the safety process can be continuously improved.