Discover how the team of experts at USDM simplified release management for a global clinical research firm transitioning to Oracle Clinical One.
The Challenge
A global clinical research company was transitioning its clinical study data to Oracle Clinical One, a comprehensive clinical trial management system. The transition surfaced a recurring problem: the company struggled to efficiently manage Oracle's frequent quarterly releases while maintaining 21 CFR Part 11 compliance with the FDA's regulatory requirements.
With limited resources and a small in-house quality and validation team, the company needed help to cope with the substantial volume of data generated by the software. Because the company also had limited knowledge of Oracle Clinical One, it was unsure whether additional compliance gaps required attention - a difficult position to be in when data integrity and audit-readiness are non-negotiable.
- Frequent quarterly releases outpaced the capacity of a small in-house team.
- Limited Oracle Clinical One knowledge created uncertainty about unaddressed compliance gaps.
- Constrained resources had to absorb a substantial volume of system data while meeting FDA expectations.
The Approach
The company sought validation expertise from USDM Life Sciences to address these challenges. USDM's comprehensive solution aimed to streamline the entire process of handling Oracle Clinical One software releases while ensuring compliance with regulatory standards. USDM leveraged its deep understanding of regulatory requirements and its expertise in system validation - grounded in modern Computer Software Assurance (CSA) thinking - to help the company achieve continuous compliance.
What USDM Delivered
USDM delivered a fully validated system for both the company's Randomization and Trial Supply Management (RTSM) module and its clinical studies. USDM also provided a comprehensive validation plan that serves as a roadmap to ensure future compliance and system reliability with every subsequent release.
To keep that validated state intact over time, USDM Cloud Assurance managed services ensure the company's system remains in a state of continuous compliance, efficiently managing the quarterly software releases from Oracle.
The Results
By engaging USDM Life Sciences, the clinical research company successfully addressed the challenges of managing frequent software releases. The comprehensive solution enabled the company to:
- Improve compliance with FDA 21 CFR Part 11 requirements across each Oracle release.
- Manage software updates efficiently by offloading quarterly release validation to USDM Cloud Assurance.
- Optimize internal resources, freeing the small in-house quality and validation team for higher-value clinical work.
- Enhance system reliability through a validated environment and a forward-looking validation plan.
What was once a quarterly scramble is now a managed, audit-ready cadence. With a fully validated RTSM module, a validation plan roadmap, and Cloud Assurance handling every Oracle release, the company turned a recurring compliance risk into a repeatable, reliable process.