From study design and data collection to monitoring and analytics, Clinical One simplifies complex workflows and accelerates trial timelines, enabling organizations to deliver results more efficiently. Its focus on flexibility, scalability, and compliance empowers sponsors, CROs, and sites to adapt to the evolving clinical landscape while maintaining high data integrity and patient safety standards.
This article explores the key capabilities and components of the Oracle Clinical One platform and its impact on the clinical trial process.
What is Oracle Clinical One?
Oracle Clinical One is a unified eClinical platform that helps organizations within the healthcare sector harmonize data, streamline workflows, and meet the critical requirements of today’s clinical trials. It supports the entire clinical trial lifecycle, from data collection to trial supplies management.
By connecting all key touchpoints across the clinical trial lifecycle in a single, unified platform, Oracle Clinical One allows for rapid data collection, reduces database build and lock timelines, and accelerates core science and clinical research initiatives.
Key Features and Benefits
Data Management
Clinical One’s intelligent data management module allows users to collect, manage, and analyze clinical trial data from multiple sources, including electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHRs).
Clinical Trial Management
The Oracle Clinical One clinical trial management solution enables users to plan, execute, and monitor clinical trials, including site management, patient recruitment, and data collection, to ensure timely execution and better preparation for future clinical trials.
Regulatory Compliance
Clinical One’s regulatory compliance module ensures that organizations comply with relevant regulations, such as Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines.
Seamless Integration
The system integrates with other Oracle Health Sciences solutions, such as Oracle Argus Safety and Oracle Life Sciences, to provide a comprehensive clinical development platform to capture data from multiple sources and streamline trial management across organizational units.
Navigating Clinical One RTSM
The Oracle Life Sciences Clinical One RTSM (Random Trial and Supply Management) provides built-in support for randomization strategies that allow users to build and modify studies without complex programming and approach clinical trials in a simpler, cost effective manner.
It provides intelligent capabilities for:
- Supply and change management initiatives
- Self-service configuration
- Drug inventory modification
- Inventory oversight
- Study promotion
- Mid-study changes
Understanding the Clinical One Digital Gateway
The Oracle Health Sciences Clinical One Digital Gateway provides an easy-to-use interface for users to create, customize, configure, monitor, and optimize all key integrations within their Oracle Life Sciences Clinical One platform. With this tool, users can integrate various applications for clinical supply services, manage integrations and their associated jobs, and monitor reports for a specific integration.
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