Download now
← Case studies
2022-04-18GovernanceContinuous complianceData

Box GxP for Controlled Clinical Management

Case study on Box GxP for Controlled Clinical Management.

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

Start here

Put AI to work in life sciences — with the right guardrails underneath.

Start with a structured AI Readiness Assessment: fixed-fee, executive-ready, and built to surface the highest-value workflows first.

  • Workflow inventory and risk classification
  • Business value and readiness scoring
  • FDA CSA + EU AI Act + ISO 42001 gap analysis
  • Prioritized 90-day roadmap by impact, risk, and effort

Start here

Talk to USDM

Tell us what workflow or outcome you want to improve and we'll map the right AI, governance, and delivery path.

By submitting this form, you agree to USDM’s Privacy Policy and consent to receive communications from USDM. You can unsubscribe at any time using the link in our emails.