The Leading Pharmacovigilance and Clinical Drug Safety Suite
Leading pharmaceutical companies and industry experts recognize Aris Global as offering the most comprehensive suite of solutions that enhance the collection, assessment and evaluation of adverse event and adverse reaction 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 supports case management, report preparation, electronic submissions (using ICH E2B) as well as benefit and risk management in accordance with international guidelines set forth by ICH, FDA, EMA and other national authorities.
Each application in the Total Safety suite can be deployed independently. When deployed together, they offer a comprehensive solution for global pharmacovigilance and clinical safety that is compliant with the legal and ethical responsibilities of both sponsors and marketing authorization holders (MAHs).
Total Safety is also available on a hosted, managed platform called agOnDemand. Numerous organizations of all sizes around the globe rely on Total Safety solutions deployed on agOnDemand.
Solutions That Cover the Full Spectrum of Drug Safety Reporting 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 solutions help enable such programs.
Total Safety is the only software suite that covers the full spectrum of safety case processing needs. The suite is comprised of the following software:
ARISg − Drug safety solution that provides all the functionality required to meet global safety reporting obligations, from clinical trial serious adverse events (SAEs) to post marketing adverse event reporting
- ARISj − ARISj (Japanese version) provides all the functionality required to meet Japanese MHLW/PMDA regulatory obligations with respect to expedited reporting and periodic reporting
- agXchange − modules for extended electronic exchange across company safety offices and with partners and regulators
- ESM - E2B Submissions Module –secure exchange of electronic drug safety data in ICH E2B format with authorities to ensure compliance and more efficient collaboration with partners
- SIR – Safety-to-Investigator Reporting – automate and track safety alert notifications to clinical investigators and ethics committees
- IRT – Inbound Receipt and Triage – harmonize processes for safety data collection across all local and regional offices using a common platform that supports different formats and media (web form, fax, email, paper)
- OST – Outbound Submissions Tacking – manage all outgoing case data reports to regulators and partners at the local level
- agSignals − System focused on user-friendly signal detection and analysis, with workflow and other tools for structured issue and signal management.
- agComposer − Workflow-guided comprehensive periodic reporting system that schedules, creates and tracks a full range of submission-ready, ICH-approved periodic reports, including PSURs, Risk Management Plans (RMPs), bridging reports and other annual reports such as the ASR. The innate flexibility of agComposer allows customers to address new and emerging needs, such as the PBRER.
- agEncoder - Web-based centralized coding and dictionary management system that codes verbatim terms (VTs) from different systems and maintains dictionaries (including MedDRA and WHO drug dictionary) at a central location. agEncoder also helps assess the impact and manages the process of MedDRA upgrades.
- agConnect - Provides significant efficiency gains by automating safety data reconciliation between clinical and safety databases.
- agHub - A safety data warehouse offering dimensional models for supporting efficient data analysis and metrics reporting; signaling (using agSignals); and aggregate listings (for agComposer).
In today's modern world, pharmacovigilance is pushing new boundaries and it is no longer sufficient to simply report adverse events and adverse reactions. Total Safety enables companies to implement and enforce proactive safety surveillance programs that include comprehensive risk management plans and pharmacovigilance signal detection and analysis throughout a product's lifecycle. Other benefits include:
- Compliance with all international safety and regulatory obligations
Ability to Leverage life science industry-standard processes
- Available via agOnDemand, a hosted, managed platform for quick, cost-effective deployment