Background
One of the top three pharmaceutical companies in Korea sought a comprehensive solution to manage its pharmacovigilance (PV) operations. Facing increasing global regulatory demands and managing high volumes of clinical and post-market safety data, the company required a system that could ensure efficient adverse event (AE) reporting, data exchange with international partners, and integration of clinical data.
From the outset, the company adopted cubeSAFETY as its primary PV platform. This solution was further strengthened by the integration of cubeCDMS, CRScube’s electronic data capture (EDC) system, leading to significant improvements in both operational efficiency and cost-effectiveness.
The company faced several key challenges as they searched for the right safety solution:
Managing large volumes of dataWith 10,000 to 15,000 new adverse events reported annually, both domestically and internationally, manual processes were inadequate. |
Regulatory complianceThe company needed to exchange XML data seamlessly with over 20 international partners to ensure accurate global safety reporting. |
Data redundancy concernsThe client wanted to reduce double data entry between EDC and safety solutions. However, they were concerned of the unreliability of data integrations, as well as the additional costs that it required. |
Solution: cubeSAFETY
The company chose cubeSAFETY for its PV operations, leveraging its advanced automation capabilities, robust regulatory reporting features, and seamless integration with cubeCDMS.
Case reporting efficiency
With 10,000 to 15,000 new AEs reported electronically each year, the client leveraged automations between cubeCDMS and cubeSAFETY to increase the efficiency of case collection, assessment, and submission process. This automation reduced the risk of human error and ensured timely submissions, enhancing compliance with global regulatory standards.
Native data exchange
The inherent real-time data flow between cubeCDMS and cubeSAFETY significantly increased the visibility of adverse events and case reports. Moreover, the client benefitted from important savings compared to the cost of integrations from other EDC vendors, making CRScube a cost-effective choice.
Data compatibility
cubeSAFETY supported the seamless exchange of XML data, ensuring consistency in safety reporting across borders. This enabled the company to meet international requirements and collaborate effectively with global stakeholders.
Results
Significant efficiency gainsThe combination of cubeSAFETY and cubeCDMS streamlined workflows, improving operational efficiency across the board. Data from clinical trials flowed directly into the PV system, reducing manual input and ensuring real-time updates. Overall case management time was significantly reduced, allowing the company to process cases faster and focus on higher-value activities like risk assessment and signal detection. |
Cost savingsBy using cubeSAFETY and cubeCDMS together, the company achieved substantial cost savings, reducing integration costs by more than 90%. Additionally, automation reduced the need for manual labor, cutting operational costs by an estimated 30%. |
Enhanced compliance and reportingThanks to cubeSAFETY, the company achieved near-perfect accuracy in case submissions, ensuring that global regulators received timely and accurate safety data. The system’s existing gateways with regulatory agencies simplified the submission of care reports and simplified the communication with agencies. |
Additional benefit
More recently, as the client considered implementing ICH E2B(R3) standards, they were pleasantly surprised to discover that CRScube made this process very simple. cubeSAFETY was one of the first PV solution to be compatible with both ICH E2B(R2) and E2B(R3). The transition between standards was done seamlessly.
Conclusion
By implementing cubeSAFETY from the start and integrating it with cubeCDMS, this leading Korean pharmaceutical company transformed its pharmacovigilance operations.
The company achieved significant improvements in operational efficiency, cost savings, and regulatory compliance while ensuring seamless collaboration with international partners. The combined solution provided a scalable, efficient, and cost-effective platform for managing a high volume of adverse events, setting the stage for continued success in global pharmacovigilance.
This leading pharmaceutical company transformed its pharmacovigilance operations by integrating cubeSAFETY with cubeCDMS.
Pharmacovigilance
A leading korean pharma optimized PV operations with cubeSAFETY
Adverse events reporting
E2B(R3) standards
EDC integration