Oracle Argus Dossier


Oracle Argus Dossier is a powerful, user-friendly collaboration platform to support the periodic report document writing and publishing process over the entire lifecycle. It will manage and plan the reporting schedule ahead of submission deadlines and reduce the time required to produce periodic dossiers.

Argus Dossier can save companies substantial full-time employee (FTE) hours and help them meet regulatory obligations in a timely manner. Its role-based workflow eliminates resource-intensive manual work and structures the publishing process. Drug safety departments can utilize Argus Dossier's advanced calendar management capability to manage the entire reporting lifecycle, from planning, collaborating, producing, and submission, down to task tracking and management.

Argus Dossier provides visibility into important data, which enables drug safety departments to collect the right information. It allows companies to maximize the time they spend on safety analysis rather than time-consuming, remedial tasks. Data will be presented in the correct context, providing a holistic picture of products with respect to their exposure over a period of time.


  • Automatically computes and populates data from any adverse event (AE) system
  • Provides management reports for resource estimation, planning, and status tracking
  • Produces audit records for all document management activities
  • Automatically distributes reporting tasks to individual team members
  • Offers customizable e-mail notification features
  • Provides ability to edit generated templates with Microsoft Word
  • Generates submission-ready dossier in PDF format with bookmarks
  • Completely interfaces with Documentum
  • Maintains full reporting schedule calendar
  • One-time configuration for auto-scheduling of periodic reports throughout the product's lifecycle
  • Generates worldwide marketing authorization table template
  • Global, standardized, and repeatable template for safety analysis reports
  • Compiles all necessary line listings when integrated with Oracle Argus Safety
  • Supports generation and inclusion of MedWatch, CIOMS II, VAERS expedited reports, line listings, summary, and other tabulations
  • Allows standard and custom templates to be used repeatedly