Oracle Argus is regarded as the ‘golden standard’ pharmacovigilance safety database. By applying a multi-tenant approach and by using the Argus workflow manager
CHANGING PV CLIMATE
The focus on risk management and early signal detection have significantly increased, extending across the entire life-cycle of a product. Together with diminishing R&D budgets and a highly specialized environment, it has become a challenge to match the regulatory requirements of an effective pharmacovigilance
In the ARGUS database, safety data are stored and can be extracted for signal management and periodic reports. It also allows to process substantial data sets of clients in a secure and efficient way, support the automation of the reconciliation and compliance reporting, and support the invoicing process, as the database is able to provide such task-specific reports.
Companies with a dataset are strongly advised to have a safety database from early development onwards, as this allows them to manage their safety data in a structured way, which is in line with the expectations of regulatory authorities. With the ARGUS safety database, we offer clients access to a first-class database managed, maintained and validated by professionals (Foresight), ensuring business contingency and management of their safety data fully compliant with regulatory standards.
The expedited reporting of ICSR to the different authorities is a regulatory requirement for sponsors of studies (SUSAR reporting) and MAHs of human and/or veterinary medicinal products and medical devices. Depending on the company and involved products we offer tailor-made solutions.
PV Query Tool
Additionally, we also provide our customers with the possibility to query the Global Safety Database to enable analysis of the safety data captured. This is a specific functionality offered by using the PV Query Tool, enabling provision of optimized
The Query Tool allows the user to create, execute, save and load ad hoc and client specific queries, which result in a case series/hit list being created when executed. The data is presented in an
- Self-service for end users
- Reduced external dependency
- Fewer custom reports / improved query response time
- Improved response to unplanned queries (audits/inspections)
- Ensures data quality and consistency
- Increased insight into your data
- Ensures data availability (querying and reporting on almost all Safety case data fields)
BENEFITS OF OUR MULTI-TENANT SOLUTION
Xendo AEM team
Our dedicated Adverse Event Management team is optimally integrated with other
As Argus is very adaptive, all process steps can be managed by
Configuration, validation, and migration are often rather challenging due to a very specific need for expertise. Therefore, our services include planning and execution from your current database to the Argus Safety Database.
- Single global safety database
- Data migration
- Case processing
- Case reconciliation/sharing – partners
- E2B and ICH-compliant
- Support data extraction for periodic reporting
- Advanced querying and reporting
- Visibility of KPIs and case processing metrics
Datasourceand support for signal detection on Argus AEs
Demo & Additional information
Please use the contact form to request a demonstration of Argus or receive additional information on how this solution might benefit your company.