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.