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"The fact that Onyx Pharmaceuticals has selected our programs to support critical business needs is great news. We believe this decision validates our approach of providing solutions that enable solid pharmacovigilance and risk management."

Onyx Pharmaceuticals


ARISg™ - Adverse Drug Event Reporting

pharmacovigilance and safety

ARISg is the world's leading pharmacovigilance and clinical safety system for good reason, with more than 300 life-sciences companies maintaining their critical safety data in ARISg worldwide.

Adverse Drug Event & Reaction Reporting Software

A comprehensive system for clinical safety and pharmacovigilance, ARISg offers unrivaled advanced software capabilities for managing adverse drug event reaction reporting. Fully scalable, ARISg can be used by small operations in the early stages of clinical trials or large organizations with worldwide pharmacovigilance operations.

Adverse Event Software

Global reporting compliance

ARISg is web-based adverse event software solution that enables the collection, assessment and reporting of adverse event information to the global regulatory agencies. ARISg ensures compliance with international adverse drug event reporting obligations, providing expedited and periodic aggregate reporting while tracking KPIs and other critical metrics.

A focus on risk management

ARISg is also core to an integrated pharmacovigilance and risk management strategy, enabling companies to monitor their products and provide early identification of product risks and safety trends.

Streamlined case processing

The configurable workflow component allows ARISg users to set up the system to meet their business processes and SOPs for the global collection, coding, assessment and reporting of the data received. This advanced workflow streamlines case processing, automating the routing of cases to individuals as defined in the workflow based on the case details.

Compliant with the reporting requirements of major regulatory agencies, ARISg facilitates the entry and assessment of cases received, preparing the cases for regulatory reporting - either electronically or via traditional reporting methods.

At-A-Glance

  • Adverse event software for clinical safety and pharmacovigilance
  • Full support for drugs, vaccines, biologics and devices
  • Compliant with international safety reporting regulations
  • Automated case routing based on company SOPs
  • Configurable and extendable user interface for efficient data entry, coding and assessment
  • Automatic case distribution based on user-defined distribution list
  • Integrated alerts and warnings
  • MedDRA browser and support for SMQs
  • Support for reporting to MHLW in Japan (ARISj™)
  • 21 CFR Part 11 Compliant

SAP Certified

Download ARISg™ Data Sheet

Aris Global data sheets now available in the Pharmacovigilance and Safety range of products.

Download ARISj™ Data Sheet Download agXchange ESM™ Data Sheet Download agXchange IRT™ Data Sheet Download agConnect™ Data Sheet Download agSignals™ Data Sheet Download agComposer™ Data Sheet
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