Delivery Order HHSN271201400013I-HHSN27100003

This is a $443,240.75 labor-hour purchase order contract awarded by the Department of Health and Human Services' National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) to Integrated Nonclinical Development Solutions Inc. (IND Solutions), a small business subchapter S corporation, to provide toxicology consultant support services for the NIH Blueprint Neurotherapeutics Network (BPN) drug discovery and development programs. The contract is a 100% small business set-aside and...

This is a firm fixed-price purchase order contract awarded by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services, to Integrated Nonclinical Development Solutions Inc. (IND Solutions), a small business. The contract is for a SEND Explorer Plus license and annual maintenance, with a ceiling value of $117,500.00 and a period of performance ending on September 30, 2019. The contract was set aside for total small business participation. IND...

This is a firm fixed-price delivery order contract awarded by the Food and Drug Administration (FDA) to Integrated Clinical Systems, Inc., a for-profit Subchapter S Corporation. The contract, valued at $779,593.50, is for the provision of software licensing, maintenance, and enhancement services in support of clinical trials data management. Integrated Clinical Systems has previously provided similar services to the National Cancer Institute and the FDA's Center for Drug Evaluation and Research....

This is a $740,907.38 firm fixed price delivery order awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Integrated Clinical Systems, Inc., a for-profit Subchapter S corporation. The contract provides JReview software licensing, maintenance, and technical support services to the FDA's Center for Drug Evaluation and Research (CDER) to support pre-market drug application reviews. Integrated Clinical Systems has previously provided similar services to the...

This is a delivery order contract awarded by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) to Societal CDMO San Diego, LLC (doing business as Irisys Inc.), a self-certified small disadvantaged business. The $704,621.50 firm-fixed-price contract is for the dosage form development, manufacture, and stability studies of the investigational drug AVE-1625 (drinabant). The work is being performed in San Diego, California. This delivery order is...

The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a firm-fixed-price purchase order contract to Integrated Nonclinical Development Solutions Inc. (IND Solutions), a small business, for FY20 Annual SEND Explorer Warehouse and Technical Support. The contract has a potential value of $179,000.00 and a period of performance from August 1, 2020 to July 31, 2021. This contract was awarded under a total small business set-aside. IND Solutions, a...

This is a $24,996.00 firm fixed price purchase order awarded by the National Cancer Institute, a civilian agency, to Integrated Clinical Systems, Inc., a for-profit S-corporation, for the provision of software licensing, maintenance, and enhancement services. The contract is for the company's JReview software, which supports risk-based monitoring and analytics for clinical trials. Integrated Clinical Systems has provided similar services to the National Cancer Institute and the Food and Drug...

The Department of Health and Human Services National Institutes of Health National Center for Advancing Translational Sciences awarded a $268,799.00 delivery order contract to Sri International for non-clinical safety assessment of ORC-13661 to support aminoglycoside induced hearing loss indication. Sri International will perform the work as the prime contractor in West Menlo Park, California from September 14, 2022 through November 13, 2023. Bioivt, LLC will serve as a subcontractor providing a...

This is a $4,734,236.00 delivery order under the "CRO Support for NCATS In Vitro and In Vivo Toxicology Studies" IDIQ contract awarded by the National Center for Advancing Translational Sciences (NCATS), a civilian agency within the Department of Health and Human Services. The award is for non-clinical safety assessment of NES100 to support an analgesia indication, with a period of performance from September 18, 2020 to April 17, 2021. The prime contractor is Battelle Memorial...

This firm fixed-price delivery order contract was awarded by the Food and Drug Administration (FDA) to Integrated Laboratory Systems, LLC (ILS), a for-profit research and testing services company. The contract, valued at $88,156.00, is for a pilot study on the in vivo genetic toxicity of the chemical NNK (nicotine-derived nitrosamine ketone) in mice using the intraperitoneal route of administration. This contract is part of a larger $7.8 million indefinite delivery contract (IDC) awarded by...