Clinical Data Management Systems
Oracle Clinical provides an integrated solution for Clinical Data Management and Remote Data Capture. RDC enables sponsors and CROs to streamline study setup and efficiently manage the execution of complex clinical trails.
USDM has developed a comprehensive solution to support Life Sciences companies with comprehensive testing of regulatory requirements for Oracle Clinical. Our Validation Accelerator Packs (VAP) provide validation assistance with core regulatory requirements for Oracle Clinical, RDC, and the Clinical Suite of products.
Business processes include:
- Study design and management
- Study Data Definition
- Study Conduct and Validation
- Data Access and Reporting
USDM’s Oracle Clinical 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 identifies upcoming patches and updates and provides a full maintenance program for our Oracle Clinical clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.
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”
