LifeSphere^® 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

• Delivers mission-critical benefits for multiple safety processes
• Serves more than 200 multi-tenant cloud customers through a comprehensive platform
• Lowers cost of ownership through multi-tenancy, cloud-based computing that eliminates the need for time-consuming, costly upgrades
• Supports full spectrum of safety case needs, including individual case safety reporting (ICSR)
• Enhances collection, assessment and evaluation of safety data
• Enables seamless integration with any case management in pharmacovigilance processing system through open architecture

The LifeSphere Modules

LifeSphere^® MultiVigilance, the first and only unified ICSR processing platform fully integrated with product complaints and medical information management.

LifeSphere^® Safety MultiVigilance, a single-global database capability for handling both clinical safety cases, including SUSARs, and post-marketing safety cases.

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^® Submissions Tracking enables companies to standardize outbound case submissions while leveraging local knowledge for local requirements.

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^® Central Coding is a sophisticated centralized coding and dictionary management system that codes verbatim terms from different sources.

LifeSphere^® Mobile MA 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.