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Specializing in the Delivery of the Argus Suite
Intrasphere is a trusted Oracle® Argus Safety Suite solutions provider to numerous Life Sciences organizations across the globe. We’re experts in implementing the full Argus Safety Suite specializing in the following products:
- Oracle Argus Safety
- Oracle Argus Insight
- Oracle Argus Perceptive
We excel in delivering the following services specific to Argus Safety:
The Intrasphere Safety practice provides clients with a full range of services including; planning, implementation, data migration, reporting and training to support organizations end-to-end processes across the drug safety and pharmacovigilance lifecycle. Our dedicated drug safety consultants are Oracle solution experts and leverage their deep knowledge of the industry to deliver solutions that are based on best practices and tailored to meet the specific business needs of our clients.
Oracle® Argus Safety Suite Implementation Specialists
Oracle's Argus Safety suite is an advanced drug safety and risk management solution. It is a proven and highly scalable system in use at global pharmaceutical companies, medical device manufacturers, biotechs, and CROs of all sizes. The Argus Safety suite is a fully integrated platform of end-to-end pharmacovigilance solutions designed to ensure regulatory compliance and comprehensive product stewardship, from clinical development all the way through post-marketing surveillance.
Intrasphere provides a full range of Argus Safety Suite implementation services. We leverage our proven delivery expertise to implement Oracle’s drug safety applications to clients in the US, Europe and Asia. We understand the business-critical interdependencies that exist between safety systems, business processes and compliance. Our drug safety experts bring to each engagement a unique mix of drug safety process and technical skills that deliver systems that maximize business efficiencies – while ensuring that operational and regulatory requirements are met.
Skilled in the intricacies of the Argus Safety Suite we help clients achieve drug safety and pharmacovigilance business objectives by providing the following services related to the solution:
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System Assessment & Selections
Configuration Strategy & Design - Analysis of business requirements to ensure the Argus Configuration Baseline Document (CSD) accurately captures settings and attributes. Includes critical aspects such as Products-Licenses-Studies-Reporting Rules, Workflow/Security, Code Lists, Letters and Reports.
Business and IT Roadmap Design
RFI / RFP Process Support
Advisory Services - Advice on industry / regulatory trends and best practices to maximize efficiencies and eliminate surprises of the Argus suite implementation & resulting usage.
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Configuration Implementation - Using the Argus Console or back-end loading methods to enter settings specific to the business needs reflected in the Argus Configuration Baseline Document (CBD).
Data Migration - Analysis of source and target systems, data profiling, data cleaning, mapping, scripting and movement of data from COTS, legacy and home-grown systems to Argus Safety.
Business Analysis (Requirements definition, business support, etc.)
Vendor Management - Coordination of vendor resources to align with project phases, tasks and framework of the overall project team.
Testing / UAT Facilitation - Management, scripting creation, dry-running and test execution to ensure the Argus Suite maps to the business requirements, CSV and 21 CFR Part 11 requirements per client standards.
Integration Design - Analysis and recommendations of how the Argus Suite can be integrated with the existing PV and/or R&D application landscape.
Deployment & Training - Planning and execution of Argus deployment activities. Customization to include company-specific data and processes. Delivery can be tailored to end-users, system administrators or train-the-trainers.
Post Production Support - Coordination and management of the vendor, IT and business support activities required to ensure an effective utilization of the Argus Suite including configuration enhancements as required.
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Online Reference Materials - Update of the field-specific help facility to reflect company specific field usage and business practices.
Investigator access to PV reports & information - Creation of portals for access to relevant safety information either with Argus or the Argus Insight Data Mart.
Analytics / Visualization & Reporting - Optimization of the usage of Argus Insight, the development and deployment of custom reports as well as setting up a query library to facilitate end-user searches in Argus and Argus Insight.
Data Warehouse / Mart for Consolidation of Safety Data - Design and configuration of Primary and Secondary Alerts, Workflow and key settings in the Argus Perceptive module.
Custom Tools & Services Training
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PV Process Analysis, Design & Metrics
Organizational Analysis, Design & Metrics
Process Deployment & Training
Change Management
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Intrasphere Develops Oracle Argus Safety Suite Technical Implementation Partner Training
Intrasphere Technologies has been contracted by Oracle to develop technical implementation focused partner training for the Oracle Argus Safety Suite. This includes development of role based, on-line Guided Learning Paths, as well as a four day hands-on classroom based Implementation Boot Camp, which will be delivered by Intrasphere under a global services delivery agreement. For more information contact us.
Oracle Health Sciences Gold Partner
As a Gold level partner Oracle recognizes Intrasphere for its commitment to Life Sciences and its in-depth expertise and excellence in delivering Oracle based drug safety solutions that uniquely address the challenges of mutual clients in the Life Sciences industry.
Learn more about Intrasphere’s Drug Safety solutions and services.
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