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 awarded a $2,082,291.00 firm fixed price definitive contract to Brigham & Women's Hospital Inc., a non-profit hospital and research institution in Boston, Massachusetts. The contract is for "Effectiveness Research with Real World Data to Support FDA's Regulatory Decision Making." It does not have a set-aside designation. Under the contract, Brigham & Women's Hospital is working closely with the FDA's...
The Department of Health and Human Services Food and Drug Administration awarded a $350,000 definitive cost-no-fee contract to Elligo Health Research, Inc. to support the agency's Broad Agency Announcement seeking proposals to extend the value of common data model harmonization in generating clinical evidence from real world data sufficient to support regulatory use. The small disadvantaged business will perform work at locations in Silver Spring, Maryland under the contract addressing the FDA's...
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...
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,...
<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 $249,999.00 definitive contract to Hartford Hospital, a non-profit hospital organization, to conduct research and development in support of regulatory science and innovation. This contract was awarded under the FDA's Broad Agency Announcement for Advanced Regulatory Science for fiscal year 2021, which solicits proposals across eight areas of regulatory science to modernize FDA functions. The contract does not have...
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...
This federal contract was awarded by the Food and Drug Administration (FDA) to Research Triangle Institute (RTI International), a non-profit research organization, for $1,135,346.55 to provide evaluation support services related to rapid assessments of state and local COVID-19 control policies. The contract is a Blanket Purchase Agreement (BPA) call under the Mission Oriented Business Integrated Services (MOBIS) Federal Supply Schedule. The contract involves RTI International as the prime...
Duke University Office of Research Administration Division was awarded a $274,413 definitive contract by the Department of Health and Human Services Food and Drug Administration to conduct a study using electronic health records to identify and assess adverse events for biologic therapies. The contract aims to develop and validate methodological approaches under the agency's Broad Agency Announcement for the Advanced Research and Development of Regulatory Science, which seeks proposals to...