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Box GxP for Controlled Clinical Management

Cybersecurity for Medical Devices

Learn how USDM implemented Box GxP in less than 30 days for a pre-commercial oncology research company. The company was already using Box to store and manage SAS datasets but needed a centralized, user-friendly solution to store controlled data in a secure and continuously compliant system. USDM’s Cloud Assurance solution helped to consolidate and optimize collaboration technologies and enhance security, data integrity, and achieve continuous compliance with Box updates.

The Situation
  • Pre-Commercial Oncology Research Company
  • Multiple Programs in Phase 2
  • Departments: IT and Clinical Data Management
  • Required clinical collaboration in a controlled, GxP compliant environment
  • Needed to maintain GxP compliance and audit readiness
The Solution
  • USDM’s Cloud Assurance team quickly implemented and validated Box GxP
  • ​End-to-end services provided by USDM and Box
  • Utilized USDM’s Cloud Assurance accelerator toolkits to confirm documents, rather than develop new documentation from scratch
  • Managed approvals with e-signatures to save time and speed up the process

The Results

  • 50% less validation time and effort through automated testing​
  • < 30 day Box GxP implementation time​
  • 50% less cost for managing SAS data sets vs. other products

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