Award Winning Solution Solves Big Pain Point for Clinical Trials

ICYMI, OpenClinica’s award-winning platform eliminates the expense and errors associated with manual abstraction of electronic health record (EHR) data into clinical trial research databases (EDCs) and case report forms (eCRFs). OpenClinica Unite™ integrates directly with site EHRs to pull out the exact data required by the trial protocol and auto-populates the trial’s EDC and eCRFs, saving time, money and effort.

Allow me to share some background.

In April, Bio-IT World announced its 2022 Innovative Practices Awards grand prize winners. The goal of the awards program is to highlight outstanding examples of how technology innovations and strategic initiatives can be applied to advance life sciences research.

The grand prize winner in the Clinical and Health IT category was Quantum Leap Healthcare Collaborative / University of California San Francisco for demonstrating a framework for integration and completion of eCRFs through automated, direct capture from EHR systems without need of manual abstraction.

Deployed at eight clinical sites in the multicenter phase 2 I-SPY-COVID-19 platform trial, an adaptive platform trial of repurposed therapeutics for patients hospitalized with severe COVID-19, we demonstrated:

• A time savings of 61 percent over sites using manual data abstraction,
• The elimination of data errors and the downstream costs associated with cleaning and validation,
• Low implementation costs and
• Reusability across sites.

OpenClinica built this technology in partnership with the Quantum Leap Healthcare Collaborative / University of California San Francisco and the U.S. Federal

Drug Administration (FDA) as a part of Operation Warp Speed, a government program created in early 2020 to accelerate the traditional clinical trial process to address the COVID-19 pandemic.

The award-winning technology is now commercially available as OpenClinica Unite™.

Just as we demonstrated in the COVID-19 trial, OpenClinica UniteTM automates source data capture with EHR-EDC integration and delivers eight key advantages:

1. Speed
2. Trial Diversity
3. Patient Centricity
4. Digital Insights
5. High Quality Data
6. Cost Reduction
7. Site Satisfaction
8. Reusability

To learn how, download our playbook, Fast-tracking clinical trials with automated source data capture.