80% Less Manual Work, 200% ROI: How Reportum® Transformed Global Pharmacovigilance Intake for a Top-10 Pharmaceutical Company
As pharmacovigilance organizations manage increasing reporting volumes and more complex compliance requirements, efficient safety data intake becomes critical. A leading top-10 pharmaceutical company recognized that its existing adverse event and product quality reporting processes were creating operational challenges, despite having a strong centralized pharmacovigilance system in place.
To modernize intake operations and improve data quality, the company implemented Reportum, Qinecsa’s digital adverse event intake platform. The result was a more efficient, scalable, and digital-first approach to safety data collection across global operations.
The Challenge: Fragmented and Manual Intake Processes
The company’s adverse event and product quality reporting workflows relied heavily on email-based processes and manual forms, particularly within Patient Support Programs (PSPs). These traditional methods created inefficiencies across the intake process.
Data Quality and Process Challenges
Key issues included:
- Incomplete or poor-quality data at initial capture.
- Repeated follow-up activities to obtain missing information from reporters.
- Manual translation, redaction, and case reconciliation tasks.
- Delays in case processing and entry into the safety database.
Although the organization had an established central pharmacovigilance system, the affiliate-based intake model remained highly manual and prone to inefficiencies.
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
A Digital-First Adverse Event Intake Platform
To address these challenges, the company deployed Reportum, a digital pharmacovigilance solution designed to support different reporter types, including PSP vendors, sales representatives, and members of the public.
Tailored Reporting Experiences
Using Reportum’s PV Design Studio, the company configured customized reporting experiences aligned to specific user personas, helping improve the quality and completeness of information captured at the source.
Global, Integrated Pharmacovigilance Workflows
The implementation included:
- Multi-language, mobile-responsive reporting experiences.
- Integration with the safety database for automated case ingestion and E2B transfer.
- Digital follow-up workflows linked to original cases and delivered in local languages.
- Self-service configuration of new PSP programs and security groups.
By designing the intake experience around the reporter, the company was able to capture more complete, accurate, and structured safety information directly from the source.
"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."
The Outcome: Improved Efficiency, ROI, and Global Scalability
The move to digital intake delivered significant operational benefits across the organization’s pharmacovigilance activities.
Measurable Operational Impact
With Reportum, the company achieved:
Up to 80% reduction in manual case handling. Direct digital intake reduced reliance on email-based booking, manual data entry, and reconciliation activities.
Up to 200% annual ROI, with additional savings opportunities identified through broader adoption of Quality Review workflows.
Global scalability, with Reportum deployed in 110 countries, supporting 14 MedDRA languages and more than 50 vendors, including specialty pharmacies and PSP providers.
The organization successfully transitioned from a reactive, manual intake model to a proactive digital-first approach that enhanced efficiency, quality, and compliance across global pharmacovigilance operations.
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.