Press Release: ArisGlobal Expands Market-Leading Safety Portfolio to Manage Pharmacovigilance Documents and Data

Available with out-of-the-box binders for Pharmacovigilance System Master File and Pharmacovigilance Agreements, Intelligent Content Management improves audit and inspection readiness while connecting teams.

MIAMI, FL, March 31, 2023– ArisGlobal, the leading provider of life sciences software designed to automate core drug development functions with its end-to-end technology platform LifeSphere®, today announces the commercial release of Intelligent Content Management for Safety, serving the industry as a singular and comprehensive product designed to organize and store extensive documentation related to safety activities. Intelligent Content Management for Safety builds on LifeSphere’s Clinical counterpart, which supports the electronic trial master file (eTMF) solution. Content management is the latest addition to the industry-leading LifeSphere Safety platform and supports the creation and maintenance of Pharmacovigilance System Master File (PSMF), Pharmacovigilance Agreements (PVA), and other mission-critical safety content.

“Intelligent Content Management can stand as the single source of truth for life sciences safety documents and make them readily accessible to improve audit and inspection readiness,” noted Beena Wood, Senior Vice President of Safety and Medical Affairs at ArisGlobal. “Moving forward, there’s a lot of potential for this technology to enable efficiency and create connections across our product portfolio.”

Key Benefits & Features of LifeSphere Intelligent Content Management

· Secure SaaS Platform with Controlled Access – secure, web-based platform for internal and external users to centrally manage safety content such as PV Agreements, Safety Data Exchange Agreements (SDEA) and other safety content.

· Content Binders – out-of-the-box PSMF and PVA binder structures with template placeholders to support audit readiness and increase compliance.

· Configurable Workflows – automatically route content for review and approval to align with business processes, and trigger workflows based on document expiration and periodic review notification.

· Comprehensive Audit Trail – enable greater compliance with detailed audit trails to log activity throughout a document’s history, including document approvers and reviewers, status changes, execution of signature and more.

· Dashboards and Reporting – standard dashboards and reporting provide transparency by allowing users to see status of content and processes.

· Electronic Signature – approve documents using electronic signatures and manifestations that are 21 CFR Part 11 compliant.

This product is a powerful operational addition to the LifeSphere Safety platform of products and is the third commercial product launched by ArisGlobal this year, following recent announcements of LifeSphere Clarity and LifeSphere Investigational Product.

Intelligent Content Management is a cross-domain offering that enables document management functionality across the LifeSphere platform. Later this year, additional domain-specific functionality for Regulatory will be introduced.