Label Change Workflow

Changing drug labels is a lengthy, tedious process and becomes more challenging when these changes have to be propagated across all the countries where the drug is marketed while adhering to the local health regulatory guidelines. Here’s how Princeton Blue transformed label change management into a streamlined and trackable process for a global pharmaceutical client.

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    About the Client

    The client is a global Fortune 100 pharmaceutical company and a leading supplier to the global Life Science industry with solutions and services for research, biotechnology development, pharmaceutical drug therapy development and production. The client’s focus areas include oncology and vaccine development.

    Business Challenge

    The current manual pharma label change workflow process wasn’t delivering the desired outcome due to the following challenges:

    • Global Spread: Label changes require complex workflows to coordinate tasks and activities across a large team that’s spread out globally.
    • Long turn-around time: Manual processes slowed down the workflow taking the client over 6 months to approve a new drug label.
    • Rigid Workflows: The company lacked a clear and defined tracking process for approvals, resulting in employees having to work with a high volume of emails.
    • Untraceable progress: Large email volumes resulted in unclear status of the approval and thus, resulted in untraceable requests with longer response times.

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      The Solution

      Princeton Blue leveraged the Appian Low-code platform to create an end-to-end workflow solution to support the pharma label update lifecycle. The solution’s purpose was to reduce the label approval cycle, provide flexible workflows, improve user experience, and enable team members to track progress.

      The solution featured a role-based simplified user experience that facilitated access to key information (process context, for example)

      when executing tasks.

      This provided greater visibility and accountability from an end-to-end perspective into the status of each approval and review. This helped in maximizing efficiency by improving the ability to identify bottlenecks and reduce compliance risks. The solution also enabled mobile access to regulatory information.

      Benefits

      After adopting the pharma label management solution, the client reported the following benefits in their label change management process:

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      Benefits

      After adopting the automated solution, the client reported the following benefits in their label change management process:
      • Reduced the new label approval cycle to under 6 months.
      • Headquarters could initiate label update submissions in real time, with country participants retroactively completing steps within a highly visible and tracked system to synchronize with real-world deadlines.
      • Inbuilt form validation in the system helped to reduce form-fill errors, improving accuracy, and reducing delays.
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