Total Safety™

Pharmacovigilance, Risk Management and Clinical Safety System

Quality. Safety. Efficacy. In the wake of recent drug withdrawals, regaining the trust of patients, healthcare providers and regulators demands that life science companies show a demonstrated commitment to safety that goes beyond mere compliance.

In today's modern world, pharmacovigilance pushes new boundaries and it is no longer sufficient to simply report adverse events. Regulators are demanding proactive surveillance programs that include

comprehensive risk management plans and Pharmacovigilance signal detection/analysis throughout a product's lifecycle.

Organizations that take the lead in developing a more proactive and long-term approach to manage the safety of their products, recognize that success requires a continuous, consistent process from the word go. This can be achieved by developing a safety posture that shows, for each product, the company was aware of and acted on every safety issue as it developed.

Total Safety Software Suite

To address today's challenges, Aris Global has developed Total Safety — a comprehensive suite of integrated software solutions that enable life science organizations, regardless of status or size, to implement effective domestic and global pharmacovigilance, clinical safety, Signal detection and risk management programs. The Total Safety suite is comprised of industry-leading solutions used globally by more than 300 direct and indirect customers.

• ARISg™ - The world's leading pharmacovigilance and clinical safety system
• ARISj™ - Japanese pharmacovigilance system
• agXchange ESM™ - Modular gateway for extended electronic exchange
• agXchange IRT™ - Inbound receipt and triage of adverse event information
• agXchange OST™ - Outbound submission tracking of adverse events
• agXchange SIR™ - Safety-to-investigator reporting
• agConnect™ - Clinical safety reconciliation system
• agEncoder™ - Centralized coding and dictionary management system
• agComposer™ - Comprehensive periodic and aggregate reporting system
• agSignals™ - Advanced pharmacovigilance signal detection and data mining system

Each software solution in the Total Safety suite is fully compliant with international regulations supporting case management, report preparation, electronic submissions and benefit/risk management in accordance with international guidelines. Each solution can be deployed independently, but when deployed together they offer a comprehensive platform for pharmacovigilance and clinical safety that is compliant with legal and ethical responsibilities of both sponsors and marketing authorization holders (MAH).