On April 29, 2022 Quantum Leap Healthcare Collaborative (QLHC) reported the award of OneSource, Quantum Leap Healthcare Collaborative’s groundbreaking clinical trial data management solution developed in collaboration with OpenClinica as the grand prize winner at the 2022 Bio-IT World Innovative Practices award in the Clinical & Health-IT category (Press release, QuantumLeap, APR 29, 2022, View Source [SID1234613244]). By integrating clinical trial data systems directly with existing electronic health records, OneSource achieves new levels of efficiency and quality control for clinical trial data management. Grand prize awards were also granted to AstraZeneca, Guardant Health with IQVIA, Merck KGaA with Genedata.

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Deployed in the ongoing I-SPY COVID-19 trial, OneSource eliminated data transcription errors that commonly occur in clinical trials laboratory and concomitant medication data, reducing time to data completion, and resulted in a greater than 50% reduction in clinical trial coordinator effort for daily data entry at a representative site. The improved fidelity and efficiency therefore offer additional key downstream costs savings in data monitoring and cleaning, which typically account for a significant portion of human resources for clinical trials.

OneSource was originally conceived in a partnership between Quantum Leap, UCSF and the Food and Drug Administration (FDA). The central concept is for critical clinical and health data to be entered only once – at the point of care – acting as a single source of truth that can be accessed for multiple secondary applications. Best-in-class interoperable systems are used to leverage existing capabilities to facilitate the collection, sharing, and reporting of structured data from authoritative sources.

"It is a fully integrated framework that allows, FDA-compliant direct communication with the EHR to improve data quality and reduce costs," said QLHC CEO James Palazzolo. "OneSource breaks new ground by creating a data quality infrastructure that enables users to improve healthcare quality, accelerate clinical research, and advance healthcare value."

As of March 1st, 2022, The I-SPY COVID trial enrolled 3,073 subjects, with 1,113 randomized subjects receiving investigational agents and 1,960 subjects in the Real World Data (RWD) cohort. QLHC and OpenClinica designed and built the software with a proof of concept (POC) in February 2021, and the first production site deployed at UCSF in May 2021. Currently, installations are in full production at 8 clinical sites using Epic electronic health record (EHR) systems, with Cerner EHR system deployments launching in April 2022.

Since 2003, Bio-IT World has hosted an elite awards program, highlighting outstanding examples of how technology innovations and strategic initiatives can be powerful forces for change in the life sciences, from basic biomedical research to drug development and beyond.

"The Bio-IT World community consistently delivers innovation to drive the life sciences forward," said Allison Proffitt, Bio-IT World Editorial Director. "This year, our panel of peer judges were particularly impressed with efforts to shift processes and data culture to empower data science and AI, with comprehensive and integrated tools for drug discovery, and with forward-thinking approaches to structuring and normalizing both clinical and real-world data.

The awards ceremony will be held during the plenary program on Tuesday, May 3, at the 2022 Bio-IT World Conference & Expo in Boston.

"It’s exciting to be recognized by Bio-IT World," said Adam Asare, QLHC Chief Data Officer/ UCSF Informatics Director for the Breast Care Center. "It’s a clear reflection of the quality of our partners and our collaborative efforts with OpenClinica, the FDA and the I-SPY program."

The low implementation costs, ease of configuration and reusability across sites is leading to expansion of implementations by mid-year for both the I-SPY COVID and the I-SPY 2 Breast Cancer Trials.

OneSource is a collaboration between members of Quantum Leap Healthcare Collaborative, UCSF, the FDA, and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The work is supported in part with federal funds from BARDA under contract number MCDC2014-001.