ArisG uses artificial intelligence to automate case processing, facilitate decision-making and make
safety workflows more efficient. It is a cloud-based solution that allows for easy updating to new regulatory
standards and global PV teams to operate in one real-time system. You can visualize reporting measures and quickly
generate compliance and local or regional regulatory reports. The safety database can be configured to individual
client’s needs, the medicinal product(s), studies, reporting requirements etc.
key features include:
Global cloud-based access with real-time review of cases
Automated coding
Automated duplicate checks
Automated validity and triage of cases
Configuration of client-based SOPs, workflows, review and reporting
procedures
Integration with other PV systems, such as safety signal management
Automated case tracking and follow-up
Real-time benefit-risk analysis
Global automated submission options
Argus Safety Databases
Argus Safety is a comprehensive global safety database that leverages automation to streamline case
processing and generate in-depth analytics and reporting. The platform is highly customizable and can be tailored to
meet the unique needs of each client, including dynamic workflows and specific reporting rules. It can also
integrate seamlessly with third-party or internal pharmacovigilance systems. By providing automated distribution and
submission of reports, Argus Safety ensures regulatory compliance through the configuration of specific rules
appropriate to the respective medicinal product(s) and offers reporting and compliance metrics to its users.
Additionally, features such as automated reporting, document storage, and integration with safety signal detection
and management make it an essential pharmacovigilance safety database. The ability to update the drug safety profile
and integrate it into risk management decision-making further enhances its value. Other key features of Argus Safety
include worldwide cloud-based access, automation assisted case processing, duplicate control, case tracking,
configuration for regional regulatory requirements, client-based rules for SOPs, workflows, review and reporting
procedures, automated submission options, options for integration with other PV processes, and audit trails to
ensure data accuracy and compliance.
Chinese Safety Databases
Regarding Chinese Local Safety Databases, sophisticated supplier like TAIMEI is the most popular on
the market due to its strength in localization of electronic transmission with China local regulatory authories and
facilitation of communication channels. However the local supplier may also experience challenges and encounter
limitations on providing the Exhaustive resolution to meet the regulatory requirement. Accestra offer consultation
with evaluation to recommend the best system/databases tailored to your company.
