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Argus Safety Web
Argus Safety Modules
Argus Affiliate
Argus Assurance
Argus Beacon
Argus Dossier
Argus Insight
Argus Interchange
Argus J  (日本語)
Argus Perceptive
Argus Reconciliation
Argus EasyTrak
Interface Products
Argus Safety™
The Industry's Leading Drug Safety System to Manage the Entire Case Lifecycle

Argus Safety™ provides the most comprehensive global Adverse Events (AE) case data management and regulatory reporting in the pharmaceutical industry. With more licensed users than any other drug safety software system in the world, Argus Safety™ is the trusted solution. 

Global Regulatory Reporting

Argus Safety™ complies with all major regulatory reporting guidelines, including EMEA, FDA and PMDA. Relsys’ proactive approach to monitoring global guidances ensures consistent regulatory compliance.  It is fully ICH:E2B compliant, enabling your company to electronically exchange information with partners and regulators.

Flexible Drug Safety Database

Argus Safety™ is a single global database allowing instant availability of a case regardless of where in the world the case originated.  The steps involved in processing individual case reports can be configured to match any unique business process, whether centralized or decentralized. Argus Safety’s ability to support any global workflow model makes it the comprehensive pharmacovigilance solution.

Scalable and High Performing  

Argus Safety™ is a proven 4th generation web-based system in use by and the most demanding and large pharmaceutical companies. This centralized and easy-to-use system delivers many benefits including simplified rollout & deployment, low long-term maintenance costs and effortless upgrades.

Fully Integrated Safety System

Argus Safety™ seamlessly integrates with Argus Insight™ and Argus Perceptive™ to deliver powerful risk management analysis tools to ensure comprehensive product stewardship. Integration with Argus Interchange™ enables electronic exchange with partners and regulators.

Argus Safety™ is the most widely used drug safety system in the world, used by small and large pharma alike. It provides businesses with peace of mind knowing that their drug safety data is being properly managed and will always meet global regulatory compliance.

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Following is a sample of reports Argus Safety™ Web supports:

  • CERFA 65-0040
  • CERFA 65-0044
  • CIOMS-I
  • CIOMS-I (Local)
  • Canadian ADR
  • Canadian Device Form
  • EU Device Vigilance Final
  • EU Device Vigilance Initial
  • EU EMEA Clinical
  • EU EMEA Spontaneous
  • French CERFA
  • German BfArM Form 643
  • German PEI Form 643
  • MCA Clinical
  • MCA Spontaneous
  • MHLW Clinical
  • MHLW Spontaneous
  • Spanish Clinical
  • Spanish Spontaneous
  • US FDA Approved MedWatch 3500A
  • US FDA Approved MedWatch 3500A Drug
  • US FDA VAERS
  • ICH-E2b for EMEA and FDA
  • ICH-E2c-Compliant PSUR
  • IND periodic report
  • NDA periodic report
  • Clinical Trial Periodic report
  • CIOMS II line listing

Drugs, Devices, and Vaccines -- based on how a product is interpreted by local regulatory authorities, Argus Safety™ allows your product to be reported as a drug in one market and as a device or a vaccine in another market.


Argus Safety™ Web fully supports all standard dictionaries including:

  • MedDRA
  • CoSTART
  • WHO-ART
  • WHO-DRUG
  • ICD-9-CM
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Argus Safety™ Web Features & Benefits

  • Compliance & Productivity metrics
  • Fully Configurable Workflow via UI
  • Automated global expedited reporting
  • Electronic Exchange
  • Automation of Narratives, Coding, Action Items and Letters (Query)
  • Case Versioning / Data Lock Point
  • Single Screen for Convenient Medical Review
  • Complaints Data Capture
  • Dashboards
  • Central Coding Support
  • Proven, 4th generation web-based system
  • Simple deployment and maintenance
  • Scalable
  • High-performing architecture
  • Low long-term maintenance costs
  • Readily upgradeable
  • Integrated Affiliate Support with Local Entry, Assessment and Reporting
  • Integrated with Clinical Systems (CDISC:ODM → ICH:E2B)
  • Fully Integrated MedDRA and WHO-Drug Browsers
  • Documentum, Cognos, Business Objects Integration
  • Source Document and Enterprise Content Management Integration
  • API for rapid integration
  • Integrated with Argus Insight and Argus Perceptive to deliver comprehensive Risk Management capability
  • Single sign-on access to all Argus suite modules
  • IT backbone integration (LDAP/ADS, Email, Fax)
  • Expedited Reporting for Drugs, Devices and Vaccines
  • Global Annual Safety Reports for Clinical and Post Marketing Surveillance
  • Easy 'Point and Click' Query By Example (QBE)
  • Ad-hoc Management Reporting
  • Management Dashboards using Operational and Risk-based Metrics
  • Key Performance Indicators like Graphical Workflow Status and Expedited Report Status with Drill Down
  • Supports compliance with Privacy laws, HIPAA, and 21 CFR Part 11 Compliant, ensuring complete auditability


Contact us for more information.

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