1 Understanding the Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP

This chapter provides an overview of the Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP. This chapter includes:

• Key Benefits of the PIP

• Participating Applications Overview

• Business Process Flow

• Solution Assumptions and Constraints

Overview

Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP automates the process of reporting adverse events for a drug or a medical device to the safety system, when Product Issues are logged in the product complaint management system.

Adverse events are entered as Product Issues in Siebel AECM. The AECM user can choose to send the Product Issue to the safety system. Siebel AECM writes messages to a queue. Product issue type indicates whether an issue is a serious adverse reaction to a drug or a medical device. The AIA layer transforms the Siebel AECM XML message into the ReportDrugSafetyReportEBM and creates an E2B+ file.

Oracle Argus Safety is an adverse event reporting and management system with an E2B+ interface. It enables you to import the files in E2B+ format and you can evaluate the files in the Oracle Argus Safety staging area. The adverse event case is then either accepted in Oracle Argus Safety as a new case or the case is appended as a follow-up to an existing case in Oracle Argus Safety. Oracle Argus Safety sends an acknowledgement message with the Safety case number when the case is created.

The Siebel AECM user may choose to send follow-ups and receive an acknowledgement from Oracle Argus Safety regarding the case. The Product Issue in Siebel AECM is updated with the case number and the date the follow-up was accepted into the safety system.

If the Oracle Argus Safety user rejects the case, a message regarding the case rejection is added to the Inbox of each product owner of the Product Issue. This acknowledgement message includes the reason for rejecting the case.

Key Benefits of the PIP

The Siebel AECM to Oracle Argus Safety integration helps eliminating error-prone and time-consuming manual processes by immediately delivering adverse events data to the Oracle Argus Safety application.

The transfer of adverse event cases from Siebel AECM to the Oracle Argus Safety is automated. This automation increases productivity and reduces the amount of reconciliation needed between the two systems. Thus, this integration aids in meeting the strict reporting timelines for adverse events.

The resulting Oracle Argus Safety unique identifier assigned to the appropriate Siebel AECM Product Issue record enhances traceability and helps to maintain the audit trail.

Participating Applications Overview

This section provides an overview of the participating applications.

Siebel Adverse Event and Complaint Management System

Siebel Adverse Event and Complaint Management system is specifically designed for medical, biotechnology, and pharmaceutical companies to improve regulatory compliance, product quality, and business performance. Siebel AECM combines a number of sub-processes that enable life sciences companies to create an integrated, traceable, and efficient adverse event and complaint management process with maximum compliance and operational efficiency.

Siebel AECM can capture and escalate complaints for investigation and regulatory reporting while maintaining a complete audit trail. This approach helps in complying with stringent regulations, thereby avoiding potential penalties for noncompliance. It enables employees to seamlessly collect adverse event and complaint information, identify the cause of the problem, and effectively assess whether the event has to be reported to the regulatory agency.

Oracle Argus Safety

Oracle Argus Safety is an advanced and comprehensive adverse events management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Oracle Argus Safety is industry-proven and accepted, having been used for more than a decade at leading pharmaceutical, biotech, CRO (Clinical Research organization), and medical device manufacturers. It also facilitates internal company safety surveillance by analyzing the overall safety profile of both investigational compounds and marketed products.

Oracle's proactive approach to monitoring global guidance enables consistent regulatory compliance. Oracle Argus Safety supports electronic communication with trading partners and CROs, providing visibility into compliance across a company's global licensing partnerships.

Oracle Argus Safety also supports a company's end-to-end pharmacovigilance program by providing a simple and efficient way to comply with international and domestic regulatory safety reporting requirements from clinical trials through post-marketing surveillance. By integrating serious adverse events from clinical trials, companies have the opportunity to manage efficacy earlier in the drug lifecycle and can potentially address public health concerns sooner. It provides the most comprehensive global adverse events case data management and regulatory reporting in the pharmaceutical industry.

Business Process Flow

All adverse event reports are promptly investigated by designated global safety specialists within strict regulatory reporting timeframes. Device and Drug Adverse Event: Siebel AECM and Argus Safety PIP automates the transfer of adverse event cases from Siebel AECM to the Oracle Argus Safety system.The Siebel AECM user logs a Service Request (SR) into Siebel AECM. An issue is created in Siebel AECM against the appropriate Product. If the issue is an adverse event, Siebel AECM user may send the case to the safety system. The case is imported into Oracle Argus Safety by the Argus Interchange functionality. You can configure Oracle Argus Safety to automatically accept all new cases. If not configured for auto-acceptance, the safety user checks the case to find out if it is a duplicate case and then accepts the case as new, or accepts the case as a follow-up to an existing case or rejects the case. An acknowledgement is returned from Oracle Argus Safety with the Safety Case Number and the date the case was accepted or a reason why it was rejected.

Figure 1-1 High Level Business Process Task Flow

Refer to the Business Process Model diagram Part 1, and 2 and the process description given below:

Figure 1-2 Business Process Model Part – 1 (Continued on next page...)

Figure 1-3 Business Process Model Part - 2

Description

The process flow description:

• An SR is entered in Siebel AECM system when a customer calls the Call Center. The Siebel AECM user creates a Product Issue for the product complaint.

• If the user feels the Product Issue should be reported to the safety group, the reportable field is set to Yes or Potential. This enables the Send to Safety button. When the user clicks this button, an XML message is written by Siebel to a JMS Queue on the SOA (Service-oriented Architecture) server.

• The Siebel Application Business Message (ABM) is transformed into the ReportDrugSafetyReportEBM.

• If Oracle Argus Interchange server is configured to auto accept incoming E2B cases, the file is immediately imported and a new case is created in Oracle Argus Safety. If auto accept incoming E2B cases is not configured, the file shows up as a Pending E2B Report in Oracle Argus Safety. The Oracle Argus Safety user can search to see if a duplicate case exists and can choose to accept the report as a new case or to accept the report as a follow-up to an existing case or reject the case.

• Oracle Argus Safety then writes an acknowledgement message. The case number is parsed out of the acknowledgement message and sent to Siebel AECM, where the Product Issue is updated with the safety system case number and the date the last information was received from Oracle Argus Safety.

• Follow-up information received by the call center may be sent to Oracle Argus Safety. The Oracle Argus Safety user can choose to append the follow-up information to the existing case or to a different case in Oracle Argus Safety. If the follow-up information is added to another case, the Safety Case ID is updated for the Product Issue in Siebel AECM to reflect the new case it was appended to.

• If the Oracle Argus Safety user rejects the case or the follow-up, a message is added to the Inbox of each product owner of the Product Issue. This message states that the Product Issue or the follow-up was rejected as a case in Oracle Argus Safety and includes the reason specified in the Oracle Argus Safety acknowledgement.

• The call center can choose to nullify the case or reject the case. The Oracle Argus Safety user has the option to manually delete the case in Oracle Argus Safety.

Logical Data Model Diagram

This section contains the Logical Data Model diagram.

Figure 1-4 Logical Model Mapping Siebel AECM and Oracle Argus Safety

Solution Assumptions and Constraints

These are the assumptions and constraints for this PIP:

• You must install the Oracle Argus Interchange module.

• There is a one-to-one mapping between a Product Issue in Siebel AECM and a Case in Oracle Argus Safety at any given point and time. You can link only one Product Issue to a particular case in Oracle Argus Safety at a given point in time; however, you can link the Product Issue to a different case at a different point in time.

• The design is based on the assumption that the Oracle Argus Safety user processes the Pending E2B Reports in the order that they were received. If the reports are not processed in the same order they were received, newer reports might be processed first and then the original report might be rejected as a duplicate.