Delivery Order 75F40123D00041-75F40123F19001
- Not listed
- The U.S. Food and Drug Administration (FDA) awarded a delivery order valued at $129,081 to Realm Research LLC, a minority-owned small disadvantaged business, on September 23, 2025. This task order falls under a larger indefinite delivery contract with a $1.1 million ceiling established in September 2023 and is set to conclude on September 27, 2028. The work involves clinical site monitoring for FDA-funded human subject research studies conducted at various domestic and international locations,...
- 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...
- This is a firm fixed price delivery order issued by the Food and Drug Administration (FDA), a civilian agency within the U.S. Department of Health and Human Services (HHS), to Spaulding Clinical Research, LLC, a self-certified small disadvantaged business. The $6,561,386.54 contract is for a range of clinical and laboratory applied regulatory science services that support the FDA's regulatory science programs and decision-making across product lifecycles. Services include conducting clinical...
- 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...
- Eastern Research Group, Inc. was awarded a $184,993 delivery order against the Department of Health and Human Services Food and Drug Administration's master indefinite-delivery/indefinite-quantity contract for Economic Studies of FDA Regulations. The delivery order is for TRACEABILITY COMPLIANCE COSTS AND COSTS FROM OVERLY BROAD RECALLS TO SUPPORT FSMA 204 ECONOMIC ANALYSIS. Work will be performed in Lexington, Massachusetts through September 2022 to provide economic analysis supporting the Food...
- The Department of Health and Human Services Food and Drug Administration awarded a $324,203.60 delivery order to Koniag Management Solutions LLC under an unspecified contract vehicle. The order is to provide two junior researchers to act as a pharmaceutical development and manufacturing specialist and as a reaction chemistry and separation specialist at the prime contractor's place of performance in Silver Spring, Maryland. The period of performance is from September 27, 2021 through September...
- This is a Firm Fixed Price delivery order awarded by the Food and Drug Administration (FDA), a civilian agency, to Eastern Research Group Inc., a for-profit Subchapter S corporation, for a study on "PATIENT EXPERIENCE DATA IN REGULATORY DECISION MAKING." The contract award, valued at $520,205.00, is associated with the FDA's Center for Drug Evaluation and Research (CDER) Priority Analysis indefinite delivery, indefinite quantity (IDIQ) contract vehicle. There is no set-aside...
- 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 Department of Health and Human Services Food and Drug Administration awarded a $348,543 delivery order to Koniag Management Solutions LLC. The task order is to obtain the services of a bioanalyst at the researcher - mid level classification to support ongoing research projects within the Division of Applied Regulatory Science. The period of performance is from September 29, 2021 through September 29, 2023. The contract utilizes a labor hours pricing structure and will be performed in...
- Eastern Research Group Inc. was awarded a $485,571 firm fixed price delivery order against the Department of Health and Human Services Food and Drug Administration's Center for Drug Evaluation and Research Priority Analysis indefinite-delivery/indefinite-quantity master contract. The order is for assessment of processes and systems to support evaluation of postmarket safety signals, to be performed over a period of approximately 18 months in Lexington, Massachusetts. No subcontractors or set...
- 75F40123D00041Indefinite Delivery Contract
- 75F40123D00041-75F40123F19001Delivery Order
Realm Research LLC, a minority-owned small disadvantaged woman-owned small business, was awarded a $34,259 firm fixed price delivery order by the Department of Health and Human Services Food and Drug Administration (FDA). The order is to provide scientific and clinical support services 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 delivery order is part of a larger $1.1 million indefinite delivery contract awarded to Realm Research in 2023 to provide broader support for monitoring extramural CDER human subject research, with the overall effort aimed at assisting the FDA in ensuring the safety and effectiveness of human drugs by overseeing externally funded clinical trials. No set-aside designation was used for the individual delivery order.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00001 | Change Order | $0 | 11/20/23 | |
| Not listed | Not listed | $34.3k | 9/29/23 |