When a global top-5 pharmaceutical company launched a groundbreaking therapy in one of its largest and most strategically important markets, the organization experienced a rapid increase in patient engagement and safety data volume. To support growth while maintaining pharmacovigilance quality and compliance standards, the company sought a more efficient approach to adverse event intake and case management.
By implementing Reportum, Qinecsa’s digital adverse event intake platform, the organization streamlined key pharmacovigilance workflows, reduced manual effort, and established a scalable foundation for future growth.
The Challenge: Managing High-Volume Safety Data at Scale
The successful launch of a blockbuster therapy generated an unprecedented surge in patient interactions and associated safety data. As reporting volumes increased, local teams faced growing operational pressure. Manual activities such as data entry, case booking, and intake management quickly became difficult to sustain at scale.
Increasing Operational Demands
Existing processes were not designed to support the volume and complexity associated with the therapy’s success. The organization needed a technology partner that could streamline workflows while ensuring compliance, quality, and continuity of pharmacovigilance operations.
The Qinecsa Approach
Simplifying Safety Data Collection
Qinecsa addressed these challenges through Reportum®, its digital adverse event intake platform designed to support direct reporting from patients, caregivers, and healthcare professionals.
The solution provides an easily accessible self-service reporting experience, helping organisations collect complete and relevant safety information at the point of first interaction.
By guiding users through structured reporting forms, Reportum® helps improve the consistency and quality of information submitted while creating a more intuitive reporting experience.
The Solution
Implementing Reportum for Digital Adverse Event Intake
The company evaluated modern digital intake technologies and identified Reportum as a solution capable of optimizing adverse event intake and related pharmacovigilance workflows.
Supporting Multiple Safety Data Collection Use Cases
Following an initial demonstration, the client recognized Reportum’s ability to support a range of use cases, including:
Specialty pharmacy programs
Patient support programs (PSPs)
Adverse event intake workflows
Related pharmacovigilance operational processes
Within months, Reportum was deployed across multiple markets and user groups, integrating into existing pharmacovigilance processes without disrupting ongoing operations.
The Outcome: Greater Efficiency, Accuracy, and Scalability
The implementation delivered measurable operational improvements and helped the organization manage increasing reporting volumes more effectively.
60% Reduction in Manual Processing Activities
By adopting Reportum, the client achieved a 60% reduction in manual case processing activities, improving operational efficiency and turnaround times. The streamlined digital intake process reduced administrative burden while supporting more efficient workflow management.
Building a Scalable Pharmacovigilance Foundation
Beyond efficiency gains, the solution enhanced data accuracy, scalability, and user satisfaction. These improvements enabled the organization to continue supporting the success of its blockbuster therapy launch while maintaining high standards of patient safety and pharmacovigilance oversight.
Continuing the Collaboration
Qinecsa continues to support the client across its portfolio, helping drive ongoing operational efficiencies and innovation in pharmacovigilance and safety data intake.
"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.