Oracle ARGUS Safety Database Solutions

ICH E2B(R3) Compliant Pharmacovigilance ARGUS Safety Database Services

Reduce Pharmacovigilance Safety Database Costs with our integrated Solution

Global Safety Database Solution

ARGUS XPDite

iSafety Multi-Tenant ARGUS SAFETY DATABASE Architecture

ARGUS XPDite is an innovative rapid deployment system to operationalize Oracle Argus Safety platform within few weeks instead of months. This is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies to expedite regulatory compliance and productivity at an accelerated scale from clinical development to post-marketing surveillance.

ARGUS XPDite: KEY FEATURES

Multi-tenant System
Multi-tenant system refers to a software architecture where multiple vendors/tenants of iSafety can access ARGUS as a single instance of a software application.

By implementing this Multi-Tenant Architecture of ARGUS database, iSafety is compliant to ICH/HL7 guidelines following regulatory standards with periodic updates (WHO DD, MedDRA coding).

We can customize fields and configure workflows in the database based on client requirements and expedite user access authorizations in a cost effective manner which saves turnaround time for project initiation and kick off.

Multi-tenancy helps iSafety management to have an overview of compliance across various projects for single or multiple vendors/tenants, this in turn aids in assessing and prioritizing work with stipulated timelines.

Cloud Set Up

By instigating ARGUS electronic database in cloud setup has its own advantages, as it optimizes the amount of time, resources and infrastructure required for implementation, validation of a regulatory complaint and effective pharmacovigilance system.

iSafety initially establishes a secure roadmap to cloud suited for individual clients needs and then provides user access which is monitored and interim support is provided by highly qualified professionals 24/7.

This also enables us to offer clients with highly expert and cost saving solutions with high scalability and flexibility in handling unexpected workloads.

Pharmacovigilance Electronic Safety Database Services

Implementation and maintenance-
iSafety implementation services for Oracle ARGUS Safety Database are strategically tailored to support customers necessities in meeting their regulatory obligations for their pharmacovigilance ICSR (Individual case safety reports) process.
We offer solutions in implementation of Oracle Argus Safety database with its latest updated version.

Hosting and Integrations
Hosting ARGUS database for a vendor include various cross functional training given by in-house experts for end user, IT and Administration.
iSafety operations and database are protected by multiple layers of defenses in our fully validated data centre with redundant power supply, and a 24/7 application support.
ARGUS XPDite integrates end-to-end safety and risk management into one comprehensive platform this makes it feasible to pull out relevant safety data for aggregate and signal reports.

Safety Data Migrations
Safety Data Migration is a complex process as majority of the organizations are transitioning to an advanced and updated electronic database which is compliant to E2B-R3 from their old safety database.

iSafety offers experts, who have extensive knowledge and experience in migrating legacy safety data on different electronic safety database systems well within required desired timelines. Our Data Migration Strategy is operative for the following models

  • Safety database like ArisG, ARGUS, Empirica Trace, AERS (version to version)
  • ARISg to ARGUS and vice versa
  • Manual Safety Data to electronic
  • Data Testing and Validation
  • Quality and Compliance Check