The Department of Health and Human Services Food and Drug Administration awarded a $300,000.00 firm-fixed-price definitive contract to Elligo Health Research, Inc., a self-certified small disadvantaged business, for a project titled "Assessing the Value of a Standard Common Data Model in the Generation of Real World Evidence for Pharmacovigilance: A Use Case." The contract was awarded on September 8, 2017, with a completion date of May 28, 2019. The place of performance is Silver...
The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a $308,625.00 purchase order contract to NMD Group, LLC, a woman-owned small business, to support the FDA's planning for real-world data and real-world evidence related to COVID-19. The contract has a completion date of September 7, 2021 and is structured as a labor hours contract. This contract award appears to be part of the FDA's efforts to accelerate planning and utilization of real-world data and...
The Department of Health and Human Services' Food and Drug Administration (FDA) awarded a $1,275,361.26 definitive cost-no-fee contract to Alliance Nctn Foundation, a non-profit organization and foundation, to conduct the "Integrating Clinical Trials and Real World Endpoints Data (ICAREDATA) Data Capture and Standardization Study". This contract, with a performance period ending on September 29, 2024, is part of the FDA's broader efforts to advance regulatory science and support...
The Department of Health and Human Services, Food and Drug Administration awarded a $5,504,791.00 firm fixed-price contract to Aetion, Inc. for real-world evidence research and development to rapidly assess the safety and effectiveness of COVID-19 countermeasures in inpatient settings. This contract was awarded under the FDA's Broad Agency Announcement for Advanced Regulatory Science, which supports ongoing regulatory science research and innovation. The contract does not have a set-aside...
The Food and Drug Administration (FDA) awarded a $4,567,087.00 cost-plus-fixed-fee delivery order contract to The Mitre Corporation, a non-profit organization, to support the FDA's Chief Data Office for real-world evidence and data agile analytics of specialized data sets. This contract, which has no set-aside designation, is part of the FDA's response to the Coronavirus (COVID-19) pandemic. The Mitre Corporation, a long-standing partner to federal agencies, will leverage its expertise in...
<p>The Department of Health and Human Services Food and Drug Administration awarded a $411,646.00 Firm Fixed Price definitive contract to Putnam Data Sciences, LLC, a woman-owned small business, for a Learning Framework for Casual Effect Estimation using Real World Data. The contract was awarded on September 25, 2019 and has a completion date of March 27, 2022. The place of performance is Silver Spring, MD. No set-aside was used for this contract award.</p>
The Department of Health and Human Services Food and Drug Administration awarded a $539,809 purchase order contract to Iqvia Government Solutions Inc. of Mosby, Virginia to provide COVID-19 real-world evidence/data agile analytics and specialized data sets. Under this contract, Iqvia will leverage its expertise in data analytics to support the FDA's efforts to monitor the real-world impact of COVID-19 through analysis of specialized data sets. The one-year contract commenced on September 29,...
This contract was awarded by the Food and Drug Administration (FDA) to Deloitte Consulting LLP to develop standards for data quality and data sources that increase the quality, interoperability, and usability of real-world data. The award is for a total ceiling value of $46,892,963.80, with a completion date of September 27, 2025. The contract is a definitive, firm fixed-price contract with no set-aside designation.
As the prime contractor, Deloitte Consulting LLP has engaged several...
The U.S. Food and Drug Administration (FDA) awarded a $200,000 delivery order contract to Realm Research LLC, a minority-owned small disadvantaged woman-owned small business, to monitor the conduct and progress of extramural FDA-funded research studies in human subjects overseen by the Center for Drug Evaluation and Research (CDER). This contract is part of a larger $1.1 million indefinite delivery contract awarded to Realm Research in 2023 to provide broader scientific and clinical support...
Yale University was awarded a definitive cost-no-fee contract valued at $3.3 million by the Department of Health and Human Services Food and Drug Administration to support the agency's Broad Agency Announcement for Advanced Research and Development of Regulatory Science. The prime contractor will leverage community engagement and electronic health record strategies to promote diverse participation in COVID-19 clinical trials, addressing Research Area 9 under the BAA which seeks proposals to...