Integrated Clinical Services
USDM offers an integrated set of clinical services and technology solutions to help life science companies of all types and sizes manage their entire clinical operations process - from Phase I through regulatory submission.
Key Services
• Study Specific User Acceptance Testing (EDC, IVRS, and ePRO)
• Clinical and Investigator Portal Solutions
• Process Analysis, Improvement and Management for Clinical Operations
• Clinical Database Programming
• Clinical Systems Integration & System Validation
• Programming/Business Analysis
• Solution and Service Vendor Requests, Vendor Selection, and Third Party Contracts
• SAS Programming | Biostatisticians Support
Clinical User Acceptance Testing and Validation Services
• Improve the efficiency of data management process and reduces go-live and database lock timelines
• Restore confidence in the clinical trial UAT process and ensure compliance from your third party vendors
• Increase ability to rapidly and accurately respond to regulatory inquiries
• Clinical study initiation process optimization program brings substantial savings and improved data quality in clinical trials
• Support proactive risk lifecycle risk management
Faster Study Start-Up and Reduced Costs through the Use of Clinical Portals
Clinical portals form a secure document repository and allow collaboration among participants which help streamline document exchange and facilitate clinical trial process improvements. For successful internal and external stakeholders exchange throughout the conduct of the study a clinical portal should:
• Be cost effective by using the Microsoft® SharePoint® platform
• Utilize user-friendly technology that can be easily embraced in the transition from paper-based processes
• Allow rapid receipt, review and approval of site compliance documentation that fosters expeditious site activation
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”
