Key Features/Benefits

Clinical and post-marketing case processing

Automated case routing based on case attributes

Facilitates compliance with ICH and Japanese safety and regulatory obligations for ICSR and Periodic Reporting

Embodies industry standard practices as a default configuration

Tracks all follow-up communications with reporters

Provides distribution lists based on regulatory reporting obligations and partner agreements

Background

Marketing Authorization Holders / product approval holders and sponsors have to meet ongoing, ever-changing regulations in the field of safety reporting.  The considerable functional needs and complexities of safety data management and reporting obligations require a system that is capable of handling the complexities involved in individual and periodic/aggregate reporting, while complying with international regulatory guidelines.

Traditionally most companies have implemented systems in-house and as safety-reporting obligations shifted rapidly, companies were often faced with a continuous cycle of costly upgrades to meet the latest compliance needs. Today the majority of companies are now looking to implement hosted solutions to reduce the burden of compliance, with the supplier taking ownership and accountability for the entire platform.

ARISg™ Spontaneous and Clinical Safety Case Management

ARISg™ provides best-in-class core case management for a modern pharmacovigilance system.  With a robust feature set embodying over 25 years of pharmacovigilance experience and best practice, ARISg and ARISj provide a single-global database capability for truly global safety case reporting.  ARISg provides multi-lingual capabilities at the database and user-interface level, and has comprehensive and configurable workflow and reporting rule capabilities for all sizes of life-science companies and regulators alike.

ARISg handles both clinical safety cases, including SUSARs, and post-marketing safety cases. A fully configurable case processing system, ARISg supports data entry compatible with both the E2B R2 and E2B R3 standards.  The system provides all the tools for efficient case processing including case entry, medical coding, quality control, medical assessment and expedited reporting, tracking all communications and follow-up activity.  Expedited and periodic reporting capabilities including PBRER, PSUR and DSUR are included with full workflow monitoring, KPIs and metrics available directly on the dashboard to ensure compliance.

Together with its active user group, ArisGlobal has defined the Industry Standard Platform (ISP) to offer an out of the box standard configuration to reduce the complexity of implementation, improve efficiency, facilitate compliance and simplify the upgrade process.Safety Investigator Reporting