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Argus Safety Database
24-05-2017

#Argus Safety Database

Oracle Argus is regarded as the ‘golden standard’ pharmacovigilance safety database. By applying a multi-tenant approach and by using the Argus workflow manager Xendo has lean processes in place enabling us to offer this software as a cost-effective solution. With this state-of-the-art database, reports for case processing can be generated independent of the size of a corporation. With the Argus Safety Database, Xendo offers the wide scope of activities to biotech, pharmaceutical, and medical device companies of all sizes looking for a cost-effective Adverse Event Management solution.

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 system, and to ensure the minimization of possible risk to patients.

ARGUS 

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 datalistings, that would normally only be available to the larger companies. Using the tool allows additional ad-hoc querying and reporting against the Argus Safety MT database.


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 easy-to use interface, where the querying fields that are selected (like Receipt Dates, Drugs, Event Terms, SMQs, Study Information, Submission Information) can be presented on one single screen and capability to add additional tailor-made listings. The fields to be included is variable, which offers a high flexibility on the data presented. These queries can be run according to the clients need for data output.

Advantages

  • 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

Dedicated Xendo AEM team

Our dedicated Adverse Event Management team is optimally integrated with other Xendo teams, like  Medical Safety Science, Auditing, QPPV and Regulatory Affairs, combining over 25 years of experience. Additionally, we are experienced with the various agencies (including PMDA, Japan), and can ensure global compliance in an ever-changing regulatory landscape.This places us in the unique position to support our clients with an end-to-end solution to pharmacovigilance. 

Flexibility

As Argus is very adaptive, all process steps can be managed by Xendo but clients can also choose to perform any of the steps internally (e.g. medical review, QC). Another possibility is that the client grants access to its own database, allowing our staff to process data on their behalf.

Implementation

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.

Activities

  • 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
  • Datasource and 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.