- Home |
- About Us |
- Products and Services |
- Support |
- Login |
- Careers |
- News & Events |
- Contact Us
Total Safety™
World’s Leading Safety and Pharmacovigilance Suite
Aris Global is recognized by leading pharmaceutical companies and industry experts for offering the most comprehensive suite of solutions that enhance the collection, assessment and evaluation of safety data.
Aris Global enables life science organizations to implement effective domestic and global pharmacovigilance, clinical safety and risk management programs. 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 Total Safety 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 (MAHs).
Total Safety is also available on a hosted, managed platform called agOnDemand. agOnDemand is successfully deployed in numerous organizations around the globe.
Solutions that cover the full spectrum of safety case needs
Organizations that take the lead in developing a more comprehensive and long-term approach to managing the safety of their products, recognize that success requires a proactive, continuous, and consistent monitoring program. Aris Global can help any size organization to develop a safety strategy that demonstrates a company was aware of and acted on every safety issue as it was identified.
Total Safety is the only software suite that covers the full spectrum of safety case needs:
- ARISg − ARISg provides all the functionality required to meet your regulatory obligations, from case entry to compliance tracking
- ARISj − ARISj (Japanese Version) provides all the functionality required to meet your regulatory obligations, from case entry to compliance tracking
- agXchange − agXchange modular gateway for extended electronic exchange
- ESM – Electronic Submission Management –secure exchange of electronic safety and clinical data with authorities to ensure compliance and more efficient collaboration with partners
- SIR – Safety-to-Investigator Reporting – automate and track the process of 'safety-to-investigator reporting'
- IRT – Inbound Receipt and Triage – manage all incoming case data information (fax, email, paper) from a common platform that also includes an easy Web interface for direct case data entry
- OST – Outbound Submission Tacking – manage all outgoing case data information
- agSignals − Safety data warehouse focused on user-friendly signal detection, risk analysis and flexible report generation
- agComposer − Workflow-guided comprehensive periodic and aggregate reporting system that schedules, creates and tracks a full range of submission-ready, ICH-approved periodic reports, including PSURs, bridging reports and other annual reports such as the ASR
- agEncoder - Web-based centralized coding and dictionary management system that codes verbatim terms (VTs) from different systems and maintains dictionaries at a central location
- agConnect - Safety data reconciliation & transfer. Continual safety data reconciliation against the safety system. Provides significant efficiency gains by automating the safety data reconciliation processes
- agOnDemand - Aris Global's hosted, manager service offering available for any Aris Global software solution.
In today's modern world, pharmacovigilance pushes new boundaries and it is no longer sufficient to simply report adverse events. Total Safety enables companies to implement and enforce proactive surveillance programs that include comprehensive risk management plans and Pharmacovigilance signal detection/analysis throughout a product's lifecycle. Other benefits include:
- Supports all products types (drugs, vaccines, biologics, device and mixed products)
- Helps implement and enforce a proactive PV and risk management strategy
- Ensures compliance with all international safety and regulatory obligations
- Leverages life science industry-standard processes
- Available via agOnDemand, a hosted, managed platform for quick, cost-effective deployment
Contact us
Email: info@arisglobal.com
Phone: Worldwide Locations
