To address these challenges, the company partnered with Qinecsa to modernize and automate its literature surveillance processes. By implementing an end-to-end technology solution, Qinecsa helped replace fragmented manual workflows with a centralized, standardized approach that improved visibility, efficiency, and control.

The Challenge

The client’s ICSR team was responsible for processing approximately 1,700 literature cases across 60 products. Managing this volume through predominantly manual processes created a significant operational burden and limited the team’s ability to work efficiently at scale.

Operational and Compliance Challenges

Several core challenges were impacting performance:

• Manual duplicate checks and classification of ICSR and non-ICSR cases.
• Excel-based workflow and quality tracking processes.
• Manual documentation and archival activities.
• Limited management oversight and increased compliance risk associated with fragmented processes.

The organization needed a more efficient and controlled operating model capable of supporting literature surveillance activities across a large and diverse product portfolio.

Qinecsa’s Approach

Qinecsa implemented a unified, end-to-end automated literature tracking platform designed to streamline literature surveillance and documentation workflows. This engagement is particularly relevant to Qinecsa’s Literature Surveillance Services, Pharmacovigilance Technology Solutions, and Automated Safety Operations capabilities.

Automated Literature Management

The platform automated the import of weekly literature search results, eliminating the need for manual intervention. Structured documentation workflows were introduced to support consistent classification and management of ICSR and non-ICSR records using configurable filters and standardized processes.

Quality Oversight and Workflow Control

To strengthen governance, the solution incorporated integrated quality control workflows and a complete audit trail. Automated workflow management and dashboard reporting provided improved visibility into operational performance and process status.

Centralized Archival and Reporting

A searchable archival repository was implemented to support efficient record management, reporting, and oversight. The platform also enabled the creation of custom reports and dashboards, helping stakeholders access information more effectively.

Solution Delivered and Outcome

The new platform replaced multiple disconnected manual processes with a centralized and standardized workflow. As a result, the client improved operational efficiency, strengthened management oversight, and enhanced regulatory compliance.

The solution delivered measurable improvements in process reliability while completely eliminating Excel-based tracking activities. The client also benefited from strengthened quality and feedback management, improved resource utilization, and a more compliant and cost-effective operating model. Qinecsa continues to support the client in identifying further opportunities for efficiency and innovation.