Oracle has recently rolled out noteworthy upgrades to its Electronic Data Capture (EDC) solution, designed to simplify clinical trial processes and enhance data management. These enhancements to Oracle Clinical One Data Collection promise to provide small business owners in the pharmaceutical and clinical research sectors with new tools to streamline workflows, improve data accuracy, and accelerate drug development.
The updated EDC solution introduces several advancements, most notably the ability to seamlessly integrate with Electronic Health Record (EHR) systems. This integration allows for efficient data transfer that eliminates the manual processes that often slow down research. By utilizing Oracle’s AI-enabled Clinical Connector, clinical sites can now transfer data securely between Oracle Health and various EHRs, which reduces the chances of error and expedites the research timeline.
“As the clinical trial landscape grows more complex, interoperability and streamlined data flow are paramount,” noted Deepu Joseph, Global Head of DM at Excelya. This sentiment resonates with small business owners looking for efficient solutions to tackle the burdens of data management in clinical trials. The capability to aggregate and manage data from multiple sources can significantly increase operational efficiency for small firms that often lack the resources of larger organizations.
The new EDC enhancements also offer improved document management capabilities. The platform now supports the upload of diverse document types alongside structured data within the EDC system. This means that site staff can utilize mobile devices to quickly add contextual information, such as scanned lab results, directly into the platform. With centralized documentation, small businesses can maintain a more comprehensive view of each subject, which in turn can accelerate research workflows and improve overall data integrity.
Moreover, the integration with safety solutions allows for quicker and more accurate reporting of serious adverse events (SAEs). By utilizing the ICH E2B(R3) standard, the Clinical One Data Collection streamlines regulatory compliance obligations, enabling clinical sites to promptly report SAEs to trial sponsors without the hassle of redundancy across disconnected systems. This feature is crucial for small businesses, offering efficiency while minimizing the risk of inaccurate data entries and quality issues.
Seema Verma, Oracle’s executive vice president and general manager in Health and Life Sciences, emphasized the importance of these innovations: “These innovations in data collection and safety can help further streamline drug development, to help improve data integrity and regulatory adherence.” For small businesses, this represents an opportunity to enhance credibility and compliance in a competitive landscape—factors that can be crucial for winning contracts and partnerships.
However, as with any new technology, small business owners should weigh the challenges associated with implementing these advanced features. Transitioning to a fully integrated EDC system may require upskilling staff and updating existing processes, which can incur costs and necessitate a change management strategy. Additionally, while the new capabilities provide greater flexibility and efficiency, businesses must ensure their teams are prepared to leverage these tools effectively.
The updates to Oracle Clinical One Data Collection will be available globally as part of the standard clinical update process, allowing small businesses to take advantage of these enhancements with relative ease. With the potential to unify data from clinical trials, streamline safety case management, and generate real-world evidence, these upgrades position Oracle as a crucial player in the future of clinical trials.
For those interested in learning more about these transformative solutions, Oracle invites attendees to its Health and Life Sciences Summit in Orlando from September 9-11, 2025. This event will showcase how Oracle’s suite of tools can unify data, enhance operational efficiency, and guide strategic decision-making for small businesses in the clinical research space. For more information, visit Oracle Life Sciences or register for the summit at Oracle Health and Life Sciences Summit.
For a detailed overview of the announcement, refer to the original press release here.
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