HaloPV - A Best in Breed Approach
Automate the most repetitive pharmacovigilance processes
Why you need to act now
Case processing was automated decades ago. Everything around it wasn't.
The surrounding processes, coordinating aggregate reports, managing PSMFs and tracking agreements - remain manual, error prone and resource intensive. Report coordinators spend considerable time chasing contributions from teams inside and outside Safety. Companies relying on SharePoint, Excel and email lack proper version control, review workflows and audit trails, creating real vulnerability during inspections.
And the administrative overhead of PV processes is typically growing faster than headcount.
Why Qinecsa
A best-in-breed approach
Select only the modules you need and target your biggest pain points in order of impact
Purpose-built for the gap
Automates key PV coordination tasks across reporting, PSMFs, term collections, agreements, risk management and oversight. round the world, should
Cloud-based, validated, audit-ready
A complete audit trail of who did what and when, ensuring inspection readiness
Seamless integration
Works with your existing PV ecosystem rather than replacing it
Built for the scale of global PV operations
Large pharmaceutical companies face enormous volumes of repetitive administrative work outside traditional case processing, coordinating hundreds of aggregate reports annually, managing multiple PSMFs, using different tools for their local PV activities, global risk management and tracking all risk minimisation activities, outdated systems for managing medical term queries and maintaining complex agreement workflows. That's expert time that should be spent on safety assessment.
HaloPV gives you the coordination layer, the audit logs and the traceability of actions you need during inspections and audits, without the homegrown system risk.
