Siebel Clinical Trial Management System Guide > Overview of Siebel Clinical Trial Management System >

About Siebel Clinical

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

Siebel Clinical supported 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, 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 study sites
• Clinical trial status and management reports for study manager and clinical research associates
• 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
• 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 trip report owner, reviewer, and approver
• Audit trail for trip report reviews and approvals
• Clinical trip report approver verification
• Mobile support for clinical trip report remote updates
• Support for the Siebel high interactivity framework and Siebel Open UI framework.

Siebel Clinical was designed to allow 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 system across the entire enterprise

Siebel Clinical supports the 21 CFR Part 11 industry standard.