The current processes for literature screening and management are siloed with discrete operating functions utilizing a combination of tools and manual processes. The usage of traditional keyword based searches without AI based context analysis and relationship extraction results in large number of articles marked as relevant inundating the end user with large volumes to review. Gap in business process and tools lead to incorrect outputs and errors incurring additional cost & re-work. The lack of alignment between the upstream literature screening and downstream functions of ICSR, PSUR and Signal processes introduces inconsistency, duplication and can lead to compliance and more importantly patient safety issues.

Quartica’s MARS AI solution filters the 80% of the noise allowing the literature staff to focus on the relevant articles. The solution automates screening, analysis and identification of drug – AE pairs including causality scores. It also supports automatic generation of E2B ICSR, content for PBRER and signal reports to automate downstream processes. The solution supports assignment of roles and responsibilities with due dates including notification and reminders. The solution also supports automated product strategy workflows, criteria with inclusion and exclusion and configurable templates and business rules (e.g., implied causality rules, case vs. non-case criteria etc.). Configurable workflows with user profiles and roles including audit trail and any metrics for tracking and inspection readiness are fully supported within the solution.