This $2,942,329 definitive cost-no-fee contract was awarded by the Food and Drug Administration (FDA) to the Alliance Nctn Foundation, a non-profit organization and foundation. The contract is for the real-world collection of radiographic images and treatment emergent adverse event data to support the next phase development of the ICAREDATA research institute. This work aims to advance regulatory science and support public health initiatives. The Alliance Nctn Foundation has received multiple...
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...
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 $749,938.00 Blanket Purchase Agreement (BPA) Call contract to the National Academy of Sciences, a non-profit organization, to conduct a workshop series examining the impact of real-world evidence on medical product development. The contract is a cost-no-fee type and does not have a set-aside designation. The National Academy of Sciences is an independent, nonprofit organization that provides objective advice on...
This is a Cost No Fee definitive contract awarded by the Food and Drug Administration (FDA) to the Arkansas Research Alliance, a non-profit organization, for "Scientific and Methodological Advancements in Liquid Biopsies to Further the Development of Lung Cancer-Based Precision Medicine." The contract has a ceiling value of $754,003.90 and a performance period ending March 31, 2019. This contract was not set aside for any particular socioeconomic program. The contract supports the...
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 $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 U.S. Food and Drug Administration (FDA) awarded a $4,400,000.00 Cost Plus Fixed Fee contract to Continuus Pharmaceuticals, Inc. to support the "ADVANCEMENT OF INTEGRATED CONTINUOUS MANUFACTURING (ICM) UNIT OPERATIONS." This definitive contract does not have a set-aside designation and is scheduled to be completed by September 29, 2019. The contract is part of the FDA's efforts to advance integrated continuous manufacturing unit operations, which is a major program focus area for...
The U.S. Food and Drug Administration (FDA) awarded a $1,046,568.62 firm-fixed price delivery order contract to Integrated Behavioral Health, Inc., a for-profit subchapter S corporation, to conduct a study on the "UNDERSTANDING THE PREVALENCE, EXPERIENCES, KNOWLEDGE, AND PERCEPTIONS OF FALSIFIED AND UNAPPROVED PHARMACEUTICALS IN AN ENRICHED POPULATION BEING ASSESSED FOR OR ENTERING SUBSTANCE USE DISORDER TREATMENT". The delivery order is part of a larger indefinite delivery contract...
This is a $296,492 prime contract awarded by the Food and Drug Administration (FDA) to the Clinical Data Interchange Standards Consortium Inc. (Cdisc), a non-profit organization that develops data standards for the healthcare industry. The contract is titled "Transforming Research through eSource and Standards" and was awarded on a firm fixed-price basis. The contract has a period of performance through September 30, 2019 and is not set aside for any special business designation....