Delivery Order HHSN271201400013I-HHSN27100001

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 $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 $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 definitive contract awarded by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH), to Integrated Laboratory Systems, LLC (ILS), a for-profit scientific research and testing services provider. The contract, valued at $299,359, is for a project titled "CYP1B1*3 Genotype and Impact on Docetaxel MOA" and has a completion date of December 12, 2014. The contract is a firm fixed-price arrangement and was not set aside for any specific...

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...

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...

This federal contract award was issued by the National Cancer Institute, a civilian agency within the Department of Health and Human Services, to Societal CDMO San Diego, LLC (doing business as Irisys Inc.), a self-certified small disadvantaged business and limited liability company. The $196,244.00 cost-plus-fixed-fee delivery order is for the manufacture of the investigational drug INDENOS (LMP744, NSC 706644) for injection in 50 mL fill sizes. Societal CDMO San Diego, a contract development...

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 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...

This is a $27,005,679.02 cost-plus-fixed-fee contract awarded by the National Institute of Environmental Health Sciences (NIEHS) to Integrated Laboratory Systems, LLC, a small business, to provide pathology peer review and pathology support services for the Division of the National Toxicology Program (DNTP) and the Division of Intramural Research (DIR) at NIEHS. The contract has an ultimate completion date of July 17, 2025. Integrated Laboratory Systems, which is a subsidiary of Inotiv, Inc., is...