Background

Keeping up with industry standards version is not necessarily an easy task, and it often comes at a high cost. In this case study, you will learn how a mid-sized biotech company decided to move to cubeSAFETY to reduce their safety reporting budget, and upgrade from E2B(R2) to E2B(R3) more easily.

The company had been using a well-established pharmacovigilance (PV) system for over a decade. This system, despite serving the company’s needs for years, became increasingly difficult to manage. As an example, the system was accessible only through Internet Explorer (IE), a browser that had long been phased out. When IE support was discontinued, this led to major system compatibility issues, requiring expensive updates.

When the pharmacovigilance team initiated the increment from ICH E2B(R2) to E2B(R3), they tackled their existing system’s challenges head on and searched for a new vendor. They had three main areas of concerns:

Transition costs

To comply with the release of the new ICH international standards, the company faced significant costs, straining its pharmacovigilance budget. Updating the system required substantial investments in both time and money.

Maintenance fees

Beyond the direct technology and transition costs, the company needed the services of an external IT vendor for the maintenance of their legacy system. This maintenance cost exceeded twice the license fee of the new system they would later adopt, placing a financial burden on the organization.

Lagging basic features

Essential PV functions, such as signal detection and electronic submission gateways, were not inherent to the system’s core capabilities. The company had to install additional modules and pay further fees for these functionalities, which increased the total cost of ownership.

Solution: cubeSAFETY

Recognizing the growing difficulties and costs associated with maintaining their legacy PV system, the biotech company decided to migrate to a newer, more efficient platform, cubeSAFETY. After thorough research and planning, they successfully transitioned over six months, achieving a more cost-effective and scalable solution.

Results

By moving to cubeSAFETY, they successfully transitioned to ICH E2B(R3) standards. They also realised the following benefits:

Cost efficiency

The company was able to reduce their safety reporting system budget by over 80% compared to the previous setup.

No hidden fees

cubeSAFETY eliminated the need for additional expenses beyond the license fee. There were no separate maintenance contracts or extra charges for essential PV functions, allowing the company to allocate resources more efficiently.

All essential functions

As a Biotech company, they appreciated the availability of all the essential functions they needed for safety reporting, without needing any additional installation or integrations. cubeSAFETY simplified the company’s budget forecasting.

Additional benefits

Improved data quality

cubeSAFETY included input validation mechanisms that flagged potential errors during data entry. This greatly improved the quality of XML outputs and reduced the need for manual interventions. As a result, all submission errors were detected at the input stage, streamlining the reporting process and enhancing data integrity.

Regulatory compliance and modernization

The company was able to connect to regulatory authorities' electronic gateways, enabling them to keep up with the latest PV reporting trends. This integration not only allowed for better regulatory compliance but also ensured that the company could operate efficiently in an increasingly digital environment.

Conclusion

This case illustrates the complex challenges organizations face when managing system upgrades driven by regulatory or international standards updates. For this biotech company, maintaining the legacy system became untenable due to high direct and indirect costs.

The transition to a newer solution enabled them to address these issues comprehensively, leading to significant cost savings, improved data accuracy, and enhanced regulatory compliance.