Box GxP implemented and validated in less than 30 days
A pre-commercial oncology research company was already using Box to store and manage SAS datasets, but it needed a centralized, user-friendly solution to store controlled clinical data in a secure and continuously compliant system. USDM's Cloud Assurance solution helped consolidate and optimize collaboration technologies, enhance security and data integrity, and achieve continuous compliance with each Box update.
The Challenge
The company had multiple drug programs in Phase 2 and needed its IT and Clinical Data Management teams to collaborate on clinical data inside a controlled, GxP-compliant environment, without slowing the science.
- Pre-commercial oncology research company with multiple programs in Phase 2
- Departments involved: IT and Clinical Data Management
- Required clinical collaboration in a controlled, GxP-compliant environment
- Needed to maintain GxP compliance and audit readiness as the platform evolved
Storing controlled clinical data in a cloud platform raises the bar on validation and 21 CFR Part 11 compliance, and every Box update risked introducing compliance drift if not managed continuously.
The Approach
USDM's Cloud Assurance team quickly implemented and validated Box GxP, delivering end-to-end services alongside Box.
- Implemented and validated Box GxP with end-to-end services provided by USDM and Box
- Used USDM's Cloud Assurance accelerator toolkits to confirm documentation rather than develop new documents from scratch
- Applied a risk-based, computer software assurance (CSA) mindset with automated testing to focus effort where it mattered
- Managed approvals with e-signatures to save time and speed up the process
Continuous compliance, not a one-time project
Because the validated environment is maintained through continuous compliance, the company stays audit-ready as Box releases updates, instead of re-validating reactively after each change.
The Results
- 50% less validation time and effort through automated testing
- Less than 30 day Box GxP implementation time
- 50% less cost for managing SAS datasets versus other products
In under a month, the oncology company moved from an uncontrolled storage setup to a secure, validated, and continuously compliant home for its controlled clinical data, cutting validation effort and SAS data management cost in half while keeping IT and Clinical Data Management aligned and audit-ready. USDM Cloud Assurance keeps that environment compliant as the platform evolves.