Ultragenic implements custom solution on Argus Safety System 8.4 for a Japan-based global biotechnology company developing precision, cell-targeting investigational therapies in its fight against cancer.
The Challenge
The client is a Japan-based global biotechnology company. They are working aggressively towards bringing to market drugs and devices to treat cancer. As a part of their regulatory commitments, the client is required to submit adverse event cases to PMDA (Pharmaceuticals and Medical Devices Agency), the regulatory agency in Japan which reviews quality, safety and efficacy of medical products marketed in the domestic market.
The client had recently upgraded their safety system to Argus 8.4, which provides an out-of-box capability of report submission to PMDA directly from the Argus platform. However, the client needed certain customizations to ensure the depth of information they could submit to the regulatory body was at par with what they had been submitting manually through the PMDA platform.
Key Deliverables
As part of the technology customizations to Argus 8.4 requested by the client, we were mandated to deliver the following:
• Expand the Nullification Report logic to accept details for each nullification reason
• Allow for submission of Concomitant Medical Device details in the E2B reporting within the Argus framework
• Build capability to select multiple health codes for every adverse event in the Health Damage Description case reporting through Argus 8.4
Our Approach (Solution)
The client’s team had been using the manual mode of adverse event report submission using the PMDA platform. When they upgraded their safety system to Argus 8.4, they observed that there were certain limitations to the amount of case details they could submit through it, viz a viz the PMDA platform.
• Nullification reason details submission: Expansion of capabilities to allow a user to enter the nullification reason details after selecting either the pre-defined reason from the drop down, or by selecting ‘other’ in case the reason was not listed. This ensured that the auto-scheduled nullification XML report contained both, the Nullification reason and Nullification reason details.
• Concomitant Medical Device information submission: Customisation of the logic for Concomitant Medical Device in the safety system to enable this information to be entered by the user through the PMDA tool within Argus as a feature enhancement.
• Health Damage Description submission: Expansion of AE Report Submission capability to allow for multiple selections of health impact codes to be made, ensuring that all adverse event causes are captured in the report.
Client Benefits
• Prevented loss of data: The customizations ensured that the client could submit all the relevant information in the PMDA report submissions through the Argus 8.4 safety system, which they were doing through the manual means on the PMDA platform.
• The customizations we built into the Safety System brought parity between the external PMDA tool and Argus 8.4 with the added advantage of automation.
• Since the submissions were made from within the Argus platform, it ensured 100% accuracy and ease of reporting.
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