Validation Accelerator Packs for Clinical and Safety Systems
Siebel Clinical Trial Management System activity management provides clinical research associates with a powerful tool to actively maintain contacts with sites, and to manage issues through to resolution. Using Siebel Clinical Trial Management System trip report tool, clinical research associates can schedule site visits based on investigators availability, site enrollment, or completed work. Prebuilt visit report templates help drive consistent business processes based on regulatory mandates and companies' standard operation procedures.
Oracle and USDM have partnered to provide a comprehensive solution to support Life Sciences companies in regulatory requirements for Siebel CTMS. Our Validation Accelerator Packs (VAP) provide validation assistance with core regulatory requirements for the following functionality:
- Investigator relationship management
- Investigator and site identification and recruitment
- Site management
- Protocol and study documentation preparation
- Case report form development and electronic data capture
- Clinical data management
- Clinical supply management
- Clinical data archiving
- Data analysis
- Monitoring and reporting
USDM’s Oracle Siebel CTMS VAP documentation provides a pre-configured content rich set of templates, ready for customization to meet both domestic and international regulations. Our documentation templates include:
- Validation Plan
- User Requirements Template
- Risk Assessment
- Functional and Design Specification
- Installation Qualification
- Operational Qualification
- Performance Qualification Template
- Trace Matrix
- Validation Summary Report
USDM works closely with Oracle to identify upcoming patches and updates, and provides a full maintenance program for our Oracle Siebel VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.
USDM has a dedicated, experienced Siebel validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance.
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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“Simplify, Unify and Optimize your business & compliance needs with USDM”
