Aris Global Software Pvt. Ltd.

ARISg

The Drug Safety Software Most Used by Pharmaceutical Companies

ARISg is the world's leading pharmacovigilance and clinical safety system, with more than 300 companies maintaining their critical drug safety data in ARISg worldwide. ARISg provides all the functionality required to manage adverse event reporting and adverse reaction requirements of different authorities around the world, from case entry to automatic generation of submission ready adverse event (AE) reports including CIOMS I, MedWatch 3500A and many more.

ARISg forms the core component of an integrated pharmacovigilance and risk management system, enabling companies to monitor their products and identify safety risks proactively. ARISg helps speed up management of adverse drug reactions with the use of its configurable workflow and advanced automation features. Users can set up a system that meets their business process and standard operating procedure (SOP) requirements more efficiently by automating the routing of cases as defined in their workflow rules.

As with all Aris Global products, ARISg is available on premise or on demand (SaaS).

Pharma_agXchange_ESM

Flexible Adverse Event and Reaction Reporting Software

ARISg offers capabilities for reporting adverse events not just for drugs but also for vaccines, biologics, devices and combination products. Flexible and fully scalable, ARISg can be used by both small companies in the early stages of clinical trials for reporting serious adverse events (SAEs) and large organizations with worldwide pharmacovigilance operations.

Other features include:

SAP
  • Single global database for supporting the drug safety requirements of multiple regions, including Europe (EMA), US (FDA CDER and CBER), Canada (Health Canada), Japan (MHLW/PMDA) and other countries following ICH standards
  • Flexible configuration that can mirror practically any business process
  • Integrated ICH E2B submission support (using agXchange ESM)
  • Integrated MedDRA browser
  • User-configurable interactive views on the homepage for visibility to basic case processing metrics
  • Extensive support for blinding and unblinding
  • Integrated communications module
  • Advanced query and ad hoc reporting capability

Advanced Capabilities for Managing Adverse Event Reporting

Used in conjunction with the other components of ArisGlobal’s Total Safety suite, ARISg provides a powerful platform for developing a comprehensive pharmacovigilance and risk management strategy. The following are just a few of the key benefits that ARISg delivers:

  • Ensures compliance with international regulatory obligations for reporting adverse events and adverse reactions
  • Automation of case processing and report distribution with configurable workflows
  • Shortens data entry, medical review and coding processes
  • Meets a company’s pharmacovigilance and clinical safety needs with a proven configurable solution