Full Integration with Argus Safety™

Argus Affiliate™ resolves a major obstacle for global pharmaceutical companies – the integration of affiliate sites into the global business process. Argus Affiliate™ works in tandem with Argus Safety™ to seamlessly integrate local affiliate sites into the world-wide safety workflow via a single case database. The central safety department retains control of the environment and the ability to provide restricted access. It therefore also provides a convenient way to integrate CROs in the safety reporting process.

Productivity Improvement

Argus Affiliate™ delivers immediate ROI by eliminating redundant data entry, paper shuffling and the need for fax/email communications. This web-based module utilizes Argus Safety’s central database and does not require additional resources to maintain the system.

Local Processing with Central Visibility

Argus Affiliate™ allows case data entry at the source, a complete case review, acceptance of the case into the central database, and determination if a case is reportable, all at the local level. Affiliate sites receive only cases that are specific to the local site and users manage and track only cases specific to their workflow. The central safety department retains full visibility and insight into all affiliate sites and decisions.

Features & Benefits

• Case Entry and Tracking
• Originate case via case entry screens
• Track local data items
• eSignature support
• Perform duplicate search
• Local Labeling
• Make local labeling calls against local datasheet/license
• View cases specific to local affiliate
• ability for several affiliates to simultaneously view and make local labeling calls against the same locked case
• Ability to view Core Documents and Global Protocol
• Work list - action items  
• Staging Area for Central to Accept or Reject submitted Affiliate Cases
• E2b Submission Capabilities directly by the Affiliate
• Querying & Reporting of Cases Received /Submitted
• Audit trail