Oracle has officially announced the launch of significant advancements for its Electronic Data Capture (EDC) solution i.e. Oracle Clinical One Data Collection.
According to certain reports, these new capabilities arrive on the scene bearing an ability to facilitate seamless interoperability with Electronic Health Record (EHR) systems, enhance data collection capabilities at trial sites, and at the same time, provide end-to-end integration with Oracle Safety One Argus.
More on that would reveal how the given updates are meticulously designed to simplify clinical workflows and eliminate data friction across systems, all for the purpose of accelerating research, improving safety reporting, and bringing therapies to market faster.
Markedly enough, the stated development was realized, by and large, on the back of collaboration with pharma industry leaders and Oracle’s CRO Growth Network collaborators.
“Our EDC enhancements underscore Oracle’s commitment to delivering AI-driven capabilities and aligning clinical research and clinical care by creating a more open healthcare ecosystem that fuels medical breakthroughs for the patients who desperately need them,” said Seema Verma, executive vice president and general manager at Oracle Health and Life Sciences. “These innovations in data collection and safety can help further streamline drug development, to help improve data integrity and regulatory adherence, while empowering researchers to conduct trials with efficiency and precision.”
Talk about the whole value proposition on a slightly deeper level, we begin from how Oracle’s latest lineup of upgrades make it possible for researchers to use the AI-enabled Oracle Clinical Connector to securely transfer data between Oracle Health, other EHRs, and Oracle Clinical One Data Collection. Such a mechanism, like you can guess, really goes the distance to remove manual busywork, as it facilitates direct, EHR data transfers that can help improve accuracy and speed research.
Next up, we must dig into a piece of detail claiming that Oracle’s enhancements scale up document management capabilities for clinical sites with site-level data collection to support all file formats at the subject level, allowing documents to be uploaded alongside structured data within the EDC system.
As a result, site staff needs, let’s say, nothing more than mobile device to upload contextual data directly into the platform, such as a subject’s scanned lab result.
The idea here is to keep documentation centralized, support a more complete view of the subject, and accelerate research workflows.
Another detail worth a mention is rooted in One Data Collection’s newly-made bid to offer integrated safety capabilities across the workflow for faster and more accurate adverse event management. This safety integration essentially banks upon the ICH E2B(R3) standard to let sites quickly and seamlessly resolve their regulatory compliance obligations,
The stated resolution involves immediately reporting the occurrence of serious adverse events (SAE) to the trial sponsor.
Not just that, the integration in question is also fully interoperable with Oracle Safety One Argus and other safety solutions, something which gives customers choice and flexibility, while simultaneously helping them to maintain compliance and efficiency across the clinical development lifecycle.
Among other things, it ought to be acknowledged that the given updates will be introduced under the division of Oracle Life Sciences a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by both large and emerging companies. These client companies, on their part, are understood to have a focus on clinical research, pharmacovigilance, as well as therapeutic development lifecycle, including pre- and post-drug launch activities.
“In today’s complex clinical trial landscape, interoperability and streamlined data flow are paramount,” said Deepu Joseph, Global Head of DM, Country Head India, Excelya. “Oracle’s focus on agnostic EHR-EDC integration and complete safety reporting within Clinical One Data Collection increases operational efficiency for sites and sponsors. This kind of robust, connected ecosystem is exactly what the industry needs, to reduce burden and accelerate studies.”