The client is a US-based Global Pharmaceutical manufacturing Organization.

When it comes to effectively monitoring and keeping track of the significant number of instances associated with pharmacovigilance, the client encountered a variety of obstacles. The organization was subject to a variety of regulatory obligations, one of which was the requirement to collect and store information from customers regarding the quality, reliability, and usefulness of the products it offered.

AiRo validated the client’s case management and tracking tool for a PV service provider. Our specialists then uploaded the ARGUS case list on the tool in a predefined excel format.

The High Volume of Pharmacovigilance Cases Created a Huge Backlog

The client struggled with managing a high volume of cases related to pharmacovigilance. This resulted in the case management process becoming overwhelming and time-consuming for the client. There were also issues with case allocation and reconciliation. This meant that there were inconsistencies in the way cases were assigned and processed, which made it difficult to ensure that all cases were being handled in a timely and appropriate manner.

Additionally, cherry-picking by case processors led to the accumulation of lengthy and complex cases towards the end of the day, which further added to the already high volume of cases that needed to be managed. Prioritization of cases based on seriousness and the due date was not possible, which made it difficult to ensure that the most urgent and important cases were being dealt with first. This resulted in the client being unable to handle urgent cases with stringent timelines, which put the client at risk of non-compliance with regulatory requirements.

AiRo Validated Case Management and Tracking Tool for Managing PV Process

To overcome the above challenges, AiRo validated the client’s case management and tracking tool for a PV service provider. Our specialists then uploaded the ARGUS case list on the tool in a predefined excel format. The tool prioritizes cases based on in-built algorithms for seriousness and due date based on contractual timelines. Allocation is done based on priority on a push basis and includes a live dashboard to track time spent on each case and the status of the case individual logged in.

Additionally, admin rights for any change in allocation rest with the supervisor. It includes two modules for case processors and Quality. Other modules can be added as required. The tool is also capable of generating reports with customizable parameters.

The Client Recorded Significant Benefits Post Deployment

The implementation of Intelligent Automation for Pharmacovigilance Case Management and Case Tracking has allowed the client to effectively address the challenges they were facing and has provided a number of benefits. This has greatly improved the client’s ability to manage and track the high volume of cases related to pharmacovigilance, making it more efficient and effective.

The implementation of this tool has provided the client with a number of benefits, including:

• The ability to handle up to 20,000 monthly case volumes across a 250-resource team seamlessly

• A live dashboard to track time spent on each case and the status of the case individual logged in

• An automated dashboard for live tracking of urgent cases

• Supervisor-controlled auto distribution of work

• Auto creation of invoices instantaneously for the service provider