NEJM Authors’ Perspective cites FDA collaboration with OneSource in discussion about Real World Evidence
More than 5 years after the passage of the 21st Century Cures Act of 2016, the terms “real-world data” (RWD) and “real-world evidence” (RWE) are being used inconsistently and sometimes interchangeably. This imprecision has complicated efforts to assess the impact of such data and evidence and hindered attempts to track their use.
Quantum Leap Healthcare Collaborative™ Announces OneSource as a Grand Prize Winner in the 2022 Bio-IT World Innovative Practices Awards
Quantum Leap Healthcare Collaborative™ (QLHC) announces 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. 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.
Natera to Present Data from the BEATRICE and I-SPY2 Trials in Early-Stage TNBC and HR+/HER2- Breast Cancer at the 2022 AACR Annual Meeting
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that it will present new data relating to its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the annual meeting of the American Association for Cancer Research taking place April 8 – 13, 2022.
OneSource Named a 2022 Innovative Practices Award Winner by Bio-IT World
Bio-ITWorld today announced the 2022 Innovative Practices Awards winners. Four grand prize awards were granted to AstraZeneca, Guardant Health with IQVIA, Merck KGaA, Darmstadt, Germany, with Genedata, and Quantum Leap Healthcare Collaborative / University of California San Francisco with OpenClinica. The awards ceremony will be held during the plenary program on Tuesday, May 3, at the 2022 Bio-IT World Conference & Expo in Boston.
UCSF, QLHC and FDA Announce Successful Deployment of Innovative Data Capture System for Clinical Care and Research
UC San Francisco (UCSF), in collaboration with the Quantum Leap Healthcare Collaborative (QLHC) and the U.S. Food and Drug Administration (FDA), has developed the OneSource system to seamlessly integrate clinical care and research data.
OneSource is an electronic data capture (EDC) system which was developed with the goal of radically streamlining the collection and distribution of patient health data for clinical trials. It is based on best practices and open-source data Electronic Health Record (EHR) integration standards to launch seamlessly within widely used EHR platforms.
