Changing drug labels for medications already on the market is a lengthy, tedious process. Inefficiencies include a poorly defined approval process and vastly different label change laws in countries where the drug is sold. The client needed a streamlined and trackable process from the moment a label change signal was initiated all the way through approval, allowing each country to accept/deny the label changes.
Current situation and pain points
- It takes the client over 6 months to approve a new drug label.
- The company lacked clearly defined approval process tracking, resulting in inundating employees with emails.
- Email volume resulted in unclear status of the approval, resulting in lengthy delays.
Using Appian, an innovative end-to-end workflow solution was created to support the label update lifecycle with the following objectives:
- Provide a role-based simplified user experience that facilitated access to key information (process context, for example) when executing tasks.
- Provide greater visibility and accountability from an end-to-end perspective into the status of each approval and review.
- Maximize efficiency by improving the ability to identify bottlenecks and reduce compliance risks.
- Enable mobile access to regulatory information.
- The solution is estimated to have reduced the new label approval cycle to under 6 months.
- Headquarters had the ability to 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.