GxPAnalytix provides a full complement of Pharmacovigilance products designed to make your organization more efficient and effective. Our intuitive software will transform your existing capabilities in case intake, analytics, operational management, and reporting. We leverage the award winning QLIK Business Intelligence platform as the technological backbone of our custom solutions built over years to meet the demands of Pharmacovigilance practitioners.
iSPARC Signal is an integrated framework, enabling PV safety surveillance scientists & medical safety physicians to interactively perform routine and ad-hoc qualitative and quantitative signal detection activities in a harmonized and efficient approach. By following a well-established workflow safety physicians are empowered to perform safety data reviews by using interactive and intuitive data visualizations without being limited to preset and restricted data outputs/data pulls. A diverse combination of visual charts, frequency tabulations, line listings, and interactive narrative reviews enable safety physicians and scientists to perform periodic and ad-hoc qualitative safety data analysis. This is complimented by robust automated disproportionality measures identifying preliminary safety observations (aka alerts or potential signals).
iSPARC is an interactive Safety Platform for Analytics, Reporting, and Compliance enabling PV/Drug Safety business to perform routine and ad-hoc regulatory compliance and operational performance activities in a harmonized and practical framework. iSPARC is comprised of multiple modular solutions, offering a customer enabling integrated framework, which provides improved business operations efficiency, compliance oversight, and inspection readiness via insightful analytics.
iSPARC is built on Qlik technology, a top ranked business intelligence data discovery platform with a global footprint, and used across all industries and geographies to visualize and explore information, generate insight, ensure oversight, and make better business decisions.
iSPARC Reconcile is an integrated framework, which enables the PV/Drug Safety Case Management team to interactively perform routine AE reconciliation activities across multiple business partners and internal business functions. In addition this module includes reconciliation and oversight capabilities for SAE and PC reconciliation activities with Clinical and Quality functions, as well as oversight of Regulatory Submissions.
By default users are presented with interactive safety data visualizations, including tabulations and listings which can be easily exported and provided to business partners per SDEA requirements or internal business functions to comply with internal SOPs. While performing such reconciliation activities users have the ability to drill-down to individual cases without leaving iSPARC Reconcile environment.