Streamlined Literature Screening and Improved Compliance at Scale
Literature surveillance plays a critical role in pharmacovigilance, helping organizations identify and evaluate potential safety information while maintaining regulatory compliance. For a top five global pharmaceutical company, managing literature surveillance across a high-volume environment had become increasingly complex, creating operational challenges for literature review, ICSR documentation, and workflow oversight.
To improve efficiency and reduce reliance on manual processes, the organization partnered with Qinecsa to implement a centralized literature management platform. The result was a more streamlined, scalable, and controlled approach to literature surveillance and case handling.
The Challenge
The client’s pharmacovigilance team received approximately 35,000 literature abstracts every month, creating a significant operational burden for literature screening and case documentation activities. Managing this volume effectively required considerable effort and introduced challenges around consistency, efficiency, and oversight.
Manual Processes Limiting Efficiency
Several critical activities depended on manual workflows, including literature abstract screening and ICSR book-in processes. The organization also relied heavily on Excel-based tracking to manage workflows, creating additional administrative effort and reducing visibility across operations.
Compliance and Documentation Challenges
Fragmented archival processes made literature documentation more difficult to manage, while manual handling increased the risk of errors and potential compliance gaps. The client needed a more standardized and scalable approach capable of supporting long-term growth and operational excellence.
The Qinecsa’s Approach
Qinecsa supported the implementation of a centralized literature management platform designed to streamline literature surveillance activities and strengthen operational controls. This engagement is particularly relevant to Qinecsa’s Literature Surveillance Services, Pharmacovigilance Technology Solutions, and ICSR Management Services.
Automation of Literature Screening Workflows
The platform introduced automated duplicate search and de-duplication capabilities, helping reduce manual effort associated with literature record management. Literature citation review and ICSR book-in workflows were also streamlined to improve efficiency and consistency.
Strengthening Governance and Oversight
A structured archival system with a complete audit trail was implemented to improve documentation management and support regulatory requirements. The platform also provided real-time workflow and quality monitoring, alongside management dashboards that enhanced operational visibility and oversight.
The Outcome
The new platform enabled Qinecsa’s literature review and ICSR book-in team to transition from manual processes to a more automated and scalable literature surveillance model. This transformation helped reduce manual workloads while creating a more efficient operational framework.
The solution also strengthened documentation quality and regulatory readiness by providing a more structured and controlled environment for literature surveillance activities. Improved transparency, workflow visibility, and scalability positioned the organization to manage future demands more effectively. Qinecsa continues to support the client as they pursue additional opportunities for operational improvement and innovation.