Discover how the team of experts at USDM simplified release management for a clinical research firm.
A global clinical research company faced the challenge of transitioning its clinical study data to Oracle Clinical One, a comprehensive clinical trial management system. However, the company encountered difficulties in efficiently managing the frequent quarterly releases – while maintaining 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. Furthermore, since the company had limited knowledge about Oracle Clinical One, they were unsure about any additional compliance gaps that might require attention.
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 the Oracle Clinical One software releases while ensuring compliance with regulatory standards. USDM leveraged its deep understanding of regulatory requirements and expertise in system validation to assist the company in achieving continuous compliance.
USDM delivered a fully validated system for both their Randomization and Trial Supply Management (RTSM) module and clinical studies. USDM also provided the company with a comprehensive validation plan serving as a roadmap to ensure future compliance and system reliability. USDM's Cloud Assurance managed services ensures that the company's system remains in a state of continuous compliance, efficiently managing the quarterly software releases from Oracle.
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, manage software updates efficiently, optimize internal resources, and enhance system reliability.