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:
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:
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