Background

Pharmacovigilance (PV) has historically focused on expedited reporting of individual case summary reports (ICSRs), and most pharmacovigilance (PV) departments have been weighed down by the time-consuming process of case management.

ArisGlobal, a pioneer in Pharmacovigilance, and with more than 30 years of safety experience, is leading the way with innovative solutions and disruptive technology to transcend all traditional PV processes.  As regulatory agencies have focused their priority on the areas of signal detection and risk management, organizations need to seriously consider a different approach that can help automate case processing tasks so focus can be applied to important, proactive activities like signal detection and benefit-risk management.

Drug Safety and Risk Management

Unlike any other safety solution on the market today, ArisGlobal’s LifeSphere Safety™ is the multi-tenant, SaaS-based Pharmacovigilance and Safety platform suite that provides customers with all the best features and functionalities of the world’s foremost safety database that leverages industry-standard processes and cognitive computing capabilities to help organizations implement effective domestic and global pharmacovigilance, clinical safety and benefit-risk management programs in full E2B(R3) compliance with the latest regulations from ICH, FDA, EMA and PMDA, including all regional variations.

Why is LifeSphere Safety™ so revolutionary?

  • With more than 50 multi-tenant cloud customers, LifeSphere Safety™ leads the way with a comprehensive multi-tenant cloud-based platform to deliver mission-critical benefits across a range of safety processes.
  • As a cloud-based and pre-validated solution, upgrades are never required to meet any current regulatory requirements, helping to lower a customer’s total cost of ownership.
  • LifeSphere Safety™ spans the full spectrum of safety case needs and enhances the collection, assessment and evaluation of safety data.
  • Because of the Open Architecture, nearly all components of the LifeSphere Safety platform can be seamlessly integrated with any case processing system including Oracle Argus.

Global Adverse Event and Medical Device Reporting is based on our 30 years of experience and industry standard practices. Also offered as a MHLW-compliant solution for Japan, this solution provides a single-global database capability for handling both clinical safety cases, including SUSARs, and post-marketing safety cases. LifeSphere Safety™ supports data entry compatible with both the E2B R2 and E2B R3 standards and provides multi-lingual capabilities at the database and user-interface level.

Signal Detection and Risk Management handles the safety intelligence, signal management and risk mitigation processes of medicinal products and delivers significant functionality, including smarter signal detection algorithms to reduce signal to noise ratio; workflows to streamline signal evaluation activities, information flows and decrease collateral documentation; a user-friendly graphical interface with improved analytics; and powerful reporting capabilities, including procedural compliance and system performance reporting capabilities.

Intake and Triage is the completely vendor-agnostic case triage tool designed as a front-end to Oracle Argus and other safety databases, for automating the receipt of adverse event data regardless of source. Users can simplify the case entry process at affiliates, license partners and even CROs, reducing training requirements while reducing costs

agXchange ESM (Electronic Safety Submissions) supports the submission and receipt of ICSRs between regulatory agencies and commercial partners, tracking MDNs and acknowledgements. agXchange ESM™ is database independent and can be used to provide electronic safety messaging capabilities to any safety system.

agXchange OST (Outbound Submission Tracking) enables companies to standardize outbound case submissions while leveraging local knowledge for local requirements. When cases are finalized in the central safety system and are ready for reporting, they can be automatically routed to individual affiliate inboxes for finalization and local submission.

agHub (Out of-the-Box Reporting and Analytics) is the comprehensive safety analytics solution with out-of-the-box integration with all LifeSphere Safety™ products for safety data analysis. agHub™ eliminates the need to manually consolidate safety data from various different sources, including those from different operating units,  affiliates and partners.

agEncoder is a centralized coding and dictionary management system thatcodes verbatim terms from different sources (typically safety systems and EDC) to automate the coding process, minimizing the amount of manual effort required. Sophisticated browsing and coding capabilities, including the use of synonyms, increase the efficiency of the coding group.

agVet is a comprehensive veterinary safety reporting system that is compliant with the CVMP and VICH specifications. Through agVet, veterinary drug manufacturers and collect, assess and report adverse events in accordance with the regulatory obligations.  With full electronic reporting, agVet™ offers an easy way to comply with the latest regulations.