The Department of Health and Human Services' Food and Drug Administration (FDA) awarded a definitive, labor-hour contract to Vergys LLC, a minority-owned small disadvantaged business, to provide budgeting governance and investment management support for the Center for Drug Evaluation and Research (CDER) Office of Business Informatics (OBI). The $3,989,983.60 contract, which does not have a set-aside designation, was awarded on September 13, 2019 and has a completion date of September 22, 2022....
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...
This is a $3,677,482.71 firm fixed price contract awarded by the Food and Drug Administration (FDA) to Synensys, LLC, a Service-Disabled Veteran-Owned Small Business. The contract is for research and development to improve the reliability, interoperability, agility, and quality of laboratory data exchanges using system safety engineering and high reliability organization methods. This contract was awarded under a Broad Agency Announcement solicitation that sought proposals to advance...
This is a $47,092,963.80 definitive, firm fixed-price contract 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 contract does not have a set-aside designation. The work is a supplemental agreement within the scope of the original BAA for Advanced Regulatory Science, which seeks proposals across eight areas of regulatory science to...
The U.S. Food and Drug Administration (FDA) awarded a $515,769.89 firm fixed price definitive contract to the University of St. Gallen, a Swiss educational institution, to conduct research and develop tools to strengthen post-market surveillance of FDA-regulated products. The objective is to apply advanced analytics and hybrid artificial intelligence to improve risk identification. This contract was awarded under the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research...
This is a $1,085,530 definitive contract awarded by the Food and Drug Administration (FDA), a civilian agency, to Genentech Inc., a foreign-owned for-profit organization, to conduct basic and applied research and development to support regulatory science and innovation. The contract is a result of the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science, which is an agency-wide effort to advance scientific knowledge in specific...
This is a firm fixed-price IT services contract awarded by the Food and Drug Administration (FDA) to Vergys LLC, a minority-owned small disadvantaged business. The contract is titled "CDER Data Management Support" and has a ceiling value of $749,940.00. The contract is an 8(a) sole source award and runs through August 31, 2017. Vergys has provided similar services to federal agencies in the past, including the Department of Defense Education Activity and the FDA. The contract is...
This is a $9,671,431.00 firm fixed-price definitive contract awarded by the Food and Drug Administration (FDA), a civilian agency, to Safe Health Systems, Inc., a self-certified small disadvantaged business. The contract is to stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes. The contract has a period of performance through March 27, 2026 and does not utilize a set-aside. No additional details about larger contract...
The Department of Health and Human Services Food and Drug Administration awarded a Firm Fixed Price Delivery Order to Vertosoft, LLC, a for-profit limited liability company, under the Multiple Award Schedule (MAS) contract vehicle. The $248,800.00 task order is for the provision of DATAROBOT AUTOMATED MACHINE LEARNING services to be performed in Silver Spring, MD. Vertosoft, a self-certified HUBZone joint venture, has received over $100 million in prior federal contracts, providing various IT...
The U.S. Department of Health and Human Services Food and Drug Administration (HHS/FDA) awarded a $219,571.92 delivery order contract to Eastern Research Group Inc. (ERG), a for-profit Subchapter S corporation, to provide database data entry and curation, dashboard database modernization, and data analytics services. This contract is a task order under the larger "Economic Studies of FDA Regulations" multiple award IDIQ contract. ERG has held several other federal contracts and task...