OpenClinica
Unite™

What if, in a single click, you could transfer EHR data into your study database? Now you can.

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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.

Unite Partners

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Perks of OpenClinica Unite™

  • Automatically populates trial case report forms with EHR data in a secure and compliant manner
  • Eliminates time consuming and error prone manual data entry (e.g., labs, medications, demographics, medical history, vitals)
  • Reduces burden on clinical research coordinators
  • Eliminates source data verification (SDV)
  • Delivers better data, faster

Seamless Patient Care Workflows

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.

With OpenClinica Unite™,
it's a Win-Win

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Sites and Site Networks

Dramatically reduce the burden for coordinators and clinicians at clinical research sites and hospital systems with OpenClinica Unite.

  • Save countless hours for overburdened coordinators and clinicians — reduce routine tasks from hours to seconds!
  • Enhance patient safety and care by tracking important metrics
  • Leverage OpenClinica Unite for multiple trials and sponsors
  • Participate in research more easily and profitably

Sponsors

Sponsors get better data, faster with OpenClinica Unite.

  • Obtain higher quality data that is cleaner and more complete
  • Get faster access to study data
  • Accelerate study timelines and decision making
  • Reduce the costly practice of 100% SDV
  • Increase site satisfaction and compliance
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Academic Research Organizations

Academic Research Organizations (AROs) leverage Unite for their own research or sponsor-initiated trials as a site.

  • Easily share and standardize EHR source data capture in multicenter clinical trials
  • Nonprofits can conduct research more easily and profitably
  • Streamline data collection among major patient registries, getting large volumes of data effortlessly

CROs

Contract Research Organizations (CROs) can offer their sites and sponsors a market-leading, innovative EHR eSource integration.

  • Gain a strategic advantage in a competitive marketplace
  • Meet deadlines more consistently
  • Deliver data to sponsors faster
  • Price studies more profitably
Regulatory Compliance with Automated EHR eSource Data Capture

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.

Site Implementation, Integration, and Standardization

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.

Ready to Learn More?

Download our informational guide to see how OpenClinica Unite bridges the gap between healthcare and clinical research.

Client Testimonials

“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

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