Aurinia’s Digital-First Pharmacovigilance Strategy Delivers Strong ROI with Reportum®
When Aurinia Pharmaceuticals launched its first FDA-approved product, LUPKYNIS® (voclosporin), in January 2021, the organization sought to establish a modern pharmacovigilance (PV) infrastructure that could support both immediate operational needs and future growth.
Rather than adopting traditional manual processes or legacy technology, Aurinia chose a digital-first approach to safety data collection. By implementing Qinecsa’s Reportum platform shortly after product launch, the company created a scalable foundation for efficient adverse event and product quality intake across its expanding portfolio. [Reportum c…y Aurinia | PDF]
The Challenge: Building a Scalable Pharmacovigilance Foundation
Launching a first approved product presents significant pharmacovigilance requirements. Aurinia needed an approach that would enable efficient collection of safety information while supporting future business growth.
Avoiding Legacy Processes from the Start
Instead of replicating older pharmacovigilance workflows or relying heavily on manual intake processes, Aurinia’s PV team made a strategic decision to implement a modern, digital-first safety data collection model. The goal was to build scalability and efficiency into the organization’s pharmacovigilance operations from day one.
"Working with Reportum’s digital-first capabilities from the very start of our first product launch has ensured that we receive high quality adverse event and product quality data more efficiently, direct from sources such as consumers, healthcare professionals, and employees. The platform has enabled us to streamline our case intake process while delivering a strong ROI. Additionally, Reportum’s scalability makes onboarding new partners, such as specialty pharmacies, seamless, keeping us agile and prepared for future portfolio and case volume growth."
The Qinecsa Approach
Implementing Reportum for Digital Safety Data Collection
In June 2021, just months after launching LUPKYNIS®, Aurinia deployed Reportum, Qinecsa’s digital adverse event and product quality intake solution, to support global safety data collection activities.
Enabling Efficient Multi-Channel Data Capture
Reportum enabled Aurinia to collect high-quality adverse event and product quality information directly from multiple stakeholder groups, including:
- Consumers
- Healthcare professionals
- Specialty pharmacy programs
This digital-first model helped streamline the collection of critical safety information while supporting consistent data capture processes across reporting channels.
The Outcome: Efficiency, Scalability, and Long-Term Value
By implementing Reportum early in its product lifecycle, Aurinia established a pharmacovigilance framework designed to support both current operations and future expansion.
Streamlined Intake and Follow-Up Workflows
The platform provides built-in workflows that help streamline intake activities and support efficient follow-up processes, helping teams manage safety information more effectively.
Supporting Growth Through Scalability
As Aurinia’s needs evolved, the scalability of the platform enabled the onboarding of new partners with greater ease, supporting the company’s ongoing growth strategy.
Delivering Measurable Business Value
Aurinia reported a strong return on investment while maintaining the flexibility needed to support future portfolio expansion and increasing case volumes. By choosing a modern solution from the outset, the company avoided the burden of legacy technology and established a foundation for long-term pharmacovigilance efficiency.
Continuing the Partnership
Qinecsa continues to support Aurinia across its portfolio, helping advance operational efficiencies and supporting ongoing innovation in safety data collection and pharmacovigilance processes.
"Direct reporting is a critical component of modern pharmacovigilance. By making adverse event reporting simpler and more accessible, Reportum® helps organisations improve data quality, reduce manual effort, and strengthen their overall safety operations."
Impact
Improving Efficiency and Data Quality
By enabling direct digital reporting, Reportum® helps organisations improve the quality and completeness of safety data while reducing operational burden across pharmacovigilance teams.
Benefits include:
- Capture of complete and relevant data at first interaction
- Reduced pressure on safety call centres
- Improved report quality
- Reduced need for follow-up activities
- Elimination of manual reconciliation processes
- Elimination of manual safety database data entry
- Reduced downstream case processing effort
Based on consolidated Qinecsa metrics, organisations using Reportum® have achieved up to a 70% reduction in safety team workload.
Supporting Modern Pharmacovigilance Operations
As pharmacovigilance teams continue to face increasing case volumes and growing regulatory expectations, digital-first adverse event intake can play an important role in improving efficiency, data quality, and reporting accessibility.
Reportum® helps pharmaceutical organisations modernise adverse event collection by enabling direct reporting from patients, caregivers, and healthcare professionals while reducing manual effort across the safety workflow.