Safety

Pharmacovigilance and Drug Safety Software Platform

ArisGlobal is leading the way with an innovative pharmacovigilance software and drug safety platform to transcend all traditional safety data management and reporting processes. Our 30-plus years of safety experience provides clients with the expertise they need to respond to a heightened regulatory focus on signal detection and risk management and address adverse event reporting. ArisGlobal’s LifeSphere Safety is a multi-tenant, cloud-based pharmacovigilance and safety suite that leverages industry standards practices that are implemented as out-of-the-box features and functionalities to transform the product lifecycle.  LifeSphere Safety is a life sciences cognitive computing platform that enable automation of core processes, such as case processing, and drive efficient pharmacovigilance, clinical safety and benefit-risk management programs. Clients achieve full E2B(R3) compliance with regulations from ICH, FDA, EMA and PMDA, including all regional variations.

The LifeSphere Safety Difference

• Unified, end-to-end safety solution with seamless integration from case receipt to benefit-risk evaluation
• The industry’s first next-generation cloud pharmacovigilance system with production-ready automation
• The preferred safety system of 9 global regulatory authorities, including the US FDA
• Incorporates best practices into a pre-validated, out-of-the-box configuration to reduce customizations and shorten implementation times; seamless upgrades delivered over the cloud
• Built in close partnership with top life sciences organizations – developed and tested with industry’s leaders

The LifeSphere Modules

LifeSphere^® MultiVigilance 10 (LSMV10), the first and only drug safety system that offers out-of-the-box unification with product quality and medical information platforms, eliminating the need for inefficient reconciliation between teams

LifeSphere^® Signal Detection and Risk Management handles the safety intelligence, signal management and risk mitigation processes of medicinal products

LifeSphere^® Intake and Triage is a vendor-agnostic case triage tool for automating the receipt of adverse event data regardless of source

LifeSphere^® LitPro is the industry’s first and only automated literature screening solution that offers system-agnostic integration with other drug safety systems

LifeSphere^® Reporting and Analytics is the comprehensive safety analytics solution with out-of-the-box integration with all LifeSphere Safety products for safety data analysis

LifeSphere^® Mobile allows for simple reporting of adverse events by all stakeholders and is available as a web-based capture solution or as a mobile app

LifeSphere^® EV Triage is a cloud-based software tool that automates the triage process of segregating and reconciling applicable cases from other non-relevant cases

LifeSphere^® Vet Safety is a comprehensive veterinary safety reporting system that enables full electronic reporting