Components of your Oracle Argus Cloud Service subscription

Your organization has subscribed to either Oracle Argus Basic Cloud Service or Oracle Argus Advanced Cloud Service.

You can access certain Argus Cloud modules, based on your subscription type:

• Oracle Argus Basic Cloud Service
• Oracle Argus Advanced Cloud Service

Oracle Argus Basic Cloud Service components

An Oracle Argus Basic Cloud Service subscription allows access to the following modules, which are the base components of Argus Cloud:

Component	Description
Oracle Argus Safety	Oracle Argus Safety enables you to: Process case intake and attachment (adverse events received via email, phone, fax, E2B) Triage with duplicate checking Note: For a fresh install or for a new cloud user, the Enable smart duplicate search option is enabled by default. For cloud users upgrading to version 8.4.3, this switch is disabled by default. Leverage company-specific workflow processing Manage comprehensive global adverse events (AE) data entry, coding, and review Perform a quality review Perform a Medical Assessment/Review - narrative, causality, seriousness, etc Produce (print, fax, E2B message email) expedited and periodic regulatory reports Perform submission tracking Perform follow-up processing Perform optional case report translation.
Oracle Argus Affiliate	Oracle Argus Affiliate enables life sciences companies to remain in global regulatory compliance by supporting affiliate sites and licensing partners. Companies gain greater visibility into pharmacovigilance activities by local affiliates and among partners, lowering risk from unanticipated reporting delays. It also increases overall case-processing efficiency by automating time-consuming tasks and eliminating the need for double data-entry and subsequent reconciliation. Oracle Argus Affiliate enables users from your company’s affiliates to manage and track cases specific to their workflow.
Oracle Argus Interchange	Oracle Argus Interchange enables electronic exchange with partners and regulators, supporting maximum efficiency and worldwide regulatory compliance. Oracle Argus Interchange is seamlessly integrated into the Oracle Argus Cloud Service. It allows companies to efficiently process adverse events and collaborate more effectively with global license partners. E2B messaging with Oracle Argus Interchange includes the following features: Schedule E2B export report View and check incoming E2B import report View E2B reports and statuses Check E2B report DTD Transmit E2B reports to multiple regulatory agencies or trading partners View acknowledgments.
Oracle Argus Dossier	Oracle Argus Dossier allows pharmaceutical companies to manage the entire lifecycle of periodic safety update report (PSUR) dossiers in a timely and efficient manner, which helps to ensure compliance and lower the cost of reporting. Oracle Argus Dossier eliminates resource-intensive, manual, periodic reporting processes and shifts the paradigm from data collection to data analysis. Oracle Argus Dossier provides Period Reporting to help you: Work with predefined report templates created by the administrator Generate Dossier reports Author or review Dossier reports.
Oracle B2B	Oracle B2B is an e-commerce gateway that enables the secure and reliable exchange of business documents between an enterprise and its trading partners. Oracle B2B supports: Business-to-business document standards, security, transports, messaging services, and trading partner management Health Level 7, which enables healthcare systems to communicate with each other Numerous industry-standard e-commerce protocols, as defined for a range of industries, including healthcare, retail, IT, telecom, electronics, manufacturing, the food industry, and more.
Oracle Argus Safety Japan (Optional)	Oracle Argus Safety Japan helps to significantly reduce the total cost of ownership for global pharmaceutical companies by eliminating the need for multiple systems, avoiding costly reconciliation issues, and completely integrating Japan into the global business process. It provides essential support for Japanese Pharmaceuticals and Medical Devices Agency (PMDA) expedited reporting in the required Kanji format. A single, global database accommodates both Kanji and Western character sets, greatly increasing the efficiency of adverse event management for the Japanese life sciences industry. Oracle Argus Safety Japan helps you: Enter Japanese case data Code using MedDRA J and J Drug dictionaries Review and report expedited and period reports in Japanese.
Safety One Intake (Optional)	Safety One Intake is an advanced pharmacovigilance system designed to optimize the handling of Adverse Event (AE) reports. It seamlessly integrates with Argus Safety and provides multiple options for submitting AE reports, including file uploads and API calls. Safety One Intake focuses on streamlining the processing of these reports by following a sequential workflow.

Oracle Argus Advanced Cloud Service components

In addition to the base components, you have also access to:

Component	Description
Oracle Argus Insight	Oracle Argus Insight is an analysis tool for safety data. It provides multidimensional and comprehensive analysis of pharmaceutical safety data for making key business decisions quickly and confidently, with a comprehensive knowledge base, an extensive report library, simplified querying and reporting, and easy data access. Oracle Argus Insight includes visibility into strategic safety case and product data across the enterprise. It uncovers key statistically significant data for managing the risk/benefit profiles of products and supports key decision-making by compiling and analyzing safety case data.
Oracle Argus Analytics	Oracle Argus Analytics provides a comprehensive safety operational metrics solution, which includes drill-down dashboards and out-of-the-box integration with Oracle Argus to view key performance indicators at a glance, facilitating a higher degree of compliance and improve cost savings and operational efficiencies. Oracle Argus Analytics: Provides access to operational data to manage workflow and support regulatory compliance Views their key performance indicators at a glance Provides visibility into safety data collection, case processing and submission workflow processes.
Oracle Argus Mart	Oracle Argus Mart integrates Oracle Argus Cloud Service with Oracle Life Sciences Empirica Signal and, as such, it brings the two halves of the Oracle Life Sciences Safety Suite together. It provides a data mart of the adverse event case data from Argus Safety transformed for optimal use by Oracle Empirica Signal for detection and analysis of internal safety signals.
(Optional) Data Replication	The Oracle Argus Data Replication Cloud Service continuously recreates a copy of Oracle Argus Cloud data into the user's target database to support integration with existing third party applications, extensions, and reporting solutions.
(Optional) Safety One Intake	Safety One Intake is an advanced pharmacovigilance system designed to optimize the handling of Adverse Event (AE) reports. It seamlessly integrates with Argus Safety and provides multiple options for submitting AE reports, including file uploads and API calls. Safety One Intake focuses on streamlining the processing of these reports by following a sequential workflow.