Oracle Argus Affiliate

PRODUCT DESCRIPTION

Oracle Argus Affiliate resolves a major obstacle for global pharmaceutical companies—the integration of affiliate sites into the global business process and case workflow. Argus Affiliate works in tandem with Oracle Argus Safety to seamlessly integrate local affiliate sites into the worldwide 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 contract research organizations (CROs) in the safety reporting process.

Argus Affiliate delivers productivity improvements and immediate return on investment by eliminating redundant data entry, paper shuffling, and the need for fax and e-mail communications. This Web-based module utilizes Argus Safety's central database and does not require additional resources to maintain the system.

Offering local processing with central visibility, Argus Affiliate allows case data entry at the source, a complete case review, and acceptance of the case into the central database, as well as determination whether 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 the cases that are specific to their workflow. The central safety department retains full visibility and insight into all affiliate sites and decisions.

FEATURES AND BENEFITS

  • Case entry and tracking
    • Originate case via case entry screens
    • Track local data items
    • Electronic signature support
  • Performing duplicate search
    • 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 and reporting of cases received and submitted
  • Audit trail