2Overview of Siebel Clinical Trial Management System

Overview of Siebel Clinical Trial Management System

This chapter provides an overview of Oracle’s Siebel Clinical Trial Management System. It includes the following topics:

About Siebel Clinical Trial Management System

Siebel Clinical Trial Managements System allows biotechnology companies, pharmaceutical companies, and CROs (clinical research organizations) to better manage the clinical trial process, maintain quality of clinical trials, and manage investigator relationships. It provides a comprehensive set of tools for CRAs (clinical research associates), clinical investigators, and site coordinators, and includes a personalized Internet portal to conduct study activities more efficiently.

The following products are supported:

  • Siebel Clinical Trial Management System

  • Siebel Clinical Trial Management System Cloud Service

Features of Siebel Clinical Trial Management System

Siebel Clinical supports the following functionality:

  • Support for full clinical trial hierarchies of Subject-Site-Region-Protocol-Program

  • Support for global trials running in multiple countries, multiple languages, and multiple currencies

  • Support for randomized trials

  • Support for multi-arm, epoch, and adaptive trials

  • Site management tools for CRAs (clinical research associates), including a site calendar, trip reports, document tracking, and payment generation

  • Personalized Internet portal to help site coordinators, clinical investigators, and CRAs better manage clinical trials over the Web

  • Project and resource management

  • A flexible audit trail engine

  • Investigator and site profiling

  • Activity and calendar management for CRAs and clinical sites

  • Clinical trial status and management reports for study manager and CRAs

  • Integrated payment tracking for sites and investigators

  • Support for multiple accounts associated with a clinical protocol

  • Support for multiple contracts associated with a clinical site

  • Subject visit templates for study staff to better plan subject visits and promote protocol adherence

  • Automatic tracking of subject status on completion of relevant visits, eliminating manual errors.

  • Clinical trip report templates for CRAs to facilitate compliance with good clinical practice (GCP)

  • Automated notification emails sent to the owner, reviewer, and approver of the trip reports

  • Audit trail for reviews and approvals of trip reports

  • Approver verification of clinical trip reports

  • Support for the Siebel Open UI framework

  • Siebel Clinical Trial Management System Cloud Service for Software as a Service (SaaS) deployments

  • Clinical operations integration for budget planning and tracking

  • Source data verification to ensure that data collected during clinical trials is complete, accurate, and verifiable

  • Support for planning and tracking of clinical training

Siebel Clinical is designed to allow CROs (clinical research organizations), pharmaceutical and biotech companies, and other clinical trial sponsors to:

  • Deploy a Web-based clinical trial management system to internal and external users.

  • Make better decisions throughout the clinical trials process, leading to more efficient use of resources and faster time to market.

  • Increase productivity of CRAs and their managers by automating repetitive tasks and allowing real-time information sharing.

  • Create sustainable competitive advantage by allowing customers to provide breakthrough service to sites and investigators.

  • Provide a solution integrated with Siebel Pharma Sales and Siebel Pharma Service to allow customers to deploy one customer management solution across the entire enterprise.

Siebel Clinical supports the 21 CFR Part 11 industry standard.

Product Modules and Options for Siebel Clinical Trial System

You can purchase many Siebel Business Applications modules and use them with Siebel Clinical Trial Management System and Siebel Life Sciences. In addition, you can purchase the optional modules that are specific to Siebel Life Sciences to provide enhanced functionality for various business processes. For information about the optional modules to use with Siebel Life Sciences and Siebel Clinical Trial Management System, contact your Oracle sales representative.

This guide documents Siebel Life Sciences with the optional modules installed. In addition, the Sample database includes data for optional modules. If your installation does not include some of these modules, then your software interface differs from that described in some sections of this guide.

The exact configuration of Siebel Life Sciences screens and views depends on your company’s configuration of Siebel Life Sciences. For more information about Siebel Life Sciences, see Siebel Life Sciences Guide.

For introductory information about using the Siebel Life Sciences interface, see Siebel Fundamentals.

Note: The Siebel Bookshelf is available on Oracle Technology Network (http://www.oracle.com/technetwork/indexes/documentation/index.html) and Oracle Software Delivery Cloud. It might also be installed locally on your intranet or on a network location.