Siebel CRM Siebel Clinical Trial Management System Guide Siebel Innovation Pack 2016 E52416-01 |
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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 high-interactivity framework and 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.