OpenClinica Unite automates source data acquisition from patient medical record systems (EHRs) to clinical trial research databases (EDCs) and case report forms (eCRFs). This secure bridge between healthcare and research eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials. OC Unite is backed by a rapidly growing network comprising over 300 sites across leading health systems.
OpenClinica Unite is easily launched by clinicians, investigators, and clinical research coordinators from within the patient’s chart in the EHR. This functionality removes the need to separately log into research applications. OpenClinica Unite also provides summaries, trends, and visualizations of key information in ways that enhance safety and data quality while also supporting clinical care. Available in both a desktop and mobile version, OpenClinica Unite allows users to safely, accurately, and efficiently view study data where and when it is most needed.
Dramatically reduce the burden for coordinators and clinicians at clinical research sites and hospital systems with OpenClinica Unite.
Sponsors get better data, faster with OpenClinica Unite.
Academic Research Organizations (AROs) leverage Unite for their own research or sponsor-initiated trials as a site.
Contract Research Organizations (CROs) can offer their sites and sponsors a market-leading, innovative EHR eSource integration.
OpenClinica Unite greatly reduces the burden of capturing regulatory-grade, structured data for participating clinical trial sites. Built with rigorous compliance in mind, OpenClinica Unite is 21 CFR Part 11 and ICH GCP compliant. Traceability to the source is also built into the solution, capturing data originator and data element identifiers per FDA 2018 EHR guidance.
OpenClinica Unite is a secure, standards-based technology that is widely accepted by health system IT departments and backed by major EHR vendors. With no software to install, implementation is lightweight and fast. A fully functioning solution is ready in 4-5 weeks with user-driven access to data that’s easily auditable. Once implemented at the site, OpenClinica Unite is immediately reusable across multiple trials and sponsors thanks to its scalable design. Lastly, not all sites need to use OpenClinica Unite. It fully supports hybrid models where select sites can be enabled.
Download our informational guide to see how OpenClinica Unite bridges the gap between healthcare and clinical research.
“The app performs exactly as expected, enabling the pulling of laboratory and medication data from our EHR at the click of a button. These features save an enormous amount of time for our clinical research coordinators, simultaneously eliminating data entry errors. Our site is now much better equipped to keep up with the demands of a data-rich clinical trial, providing key results to the study sponsor much more promptly.”– Principal Solutions Architect
“Implementing this app was a strategic decision to reduce the transcription errors and the associated time with transcribing medications and labs from our study records to OpenClinica. The implementation was quick and easy in comparison to other implementations. We received excellent support from the OpenClinica team. They were available and ready to help our strong internal team and we were able to shave a full week off our initial projection.”– Project Director, Research/Executive
“The app imports lab and medication data directly from the Epic Chart to the OpenClinica platform, raising data quality and saving an extraordinary amount of time for our Coordinators. Our clinicians have access to summary displays melding research data from OpenClinica with records from the patient’s chart in a way that is not feasible for either system to do on its own. We can’t recommend the OpenClinica app and team enough, and we are thankful our collaboration continues with other high-visibility projects!”– IT User
Check out our free tools and thought leadership to learn more about clinical data management, electronic data capture, ePRO/eCOA, decentralized clinical research, and more!
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