Definitive Contract W911QY09C0104

The Department of Health and Human Services' Food and Drug Administration awarded a $611,141 firm fixed price definitive contract to Clarivate Analytics (Us) LLC for a Cortellis Clinical Trials software license. Under this contract, Clarivate Analytics will provide its Cortellis Clinical Trials software to support the FDA's clinical research programs. No major subcontractors or set aside designations were identified. The Cortellis Clinical Trials software will be licensed for use at the FDA's...

This is a firm fixed price delivery order contract awarded by the U.S. Food and Drug Administration (FDA) to Spaulding Clinical Research, LLC, a self-certified small disadvantaged business. The $5,454,071.53 contract is for the provision of clinical and laboratory applied regulatory science services to support the FDA's regulatory science programs and assist with regulatory decision-making across product lifecycles. The services include conducting clinical pharmacology studies, QT prolongation...

This federal contract award to PPD Development LP, a global contract research organization (CRO), provides regulatory consulting assistance for a medical device developer under the Blueprint MedTech program. The $370,621 cost-plus-fixed-fee contract includes research and development for clinical studies, pre-submission assessment, and package preparation. The award is issued by the National Institute on Drug Abuse, a civilian agency, and is not set aside. PPD Development LP is a subsidiary of...

This is a $3,973,303.00 delivery order awarded by the National Library of Medicine (part of the Department of Health and Human Services) to ICF Incorporated, L.L.C., a global consulting and technology services company. The delivery order provides operations, maintenance, and modernization support for the ClinicalTrials.gov website, which is a database of privately and publicly funded clinical studies conducted around the world. The contract is not set aside for any specific business type and...

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' Food and Drug Administration awarded a firm fixed price delivery order contract to Integrated Clinical Systems, Inc., a for-profit Subchapter S corporation, for JREVIEW SERVICES. The contract, valued at $826,997.10, has a completion date of September 21, 2018 and was awarded on August 23, 2017. Integrated Clinical Systems has previously provided software licensing, maintenance, and enhancement services in support of clinical trials data management...

This is a firm fixed-price contract awarded by the Food and Drug Administration (FDA), a civilian agency, to Accenture Federal Services LLC, a subsidiary of the global professional services firm Accenture plc. The contract is for CLINICAL DATA SAFETY ANALYSIS services with an ultimate completion date of April 27, 2027 and a ceiling value of $1,894,776.76. The contract was awarded on April 23, 2025 and was placed as a call against Accenture's existing Multiple Award Schedule (MAS) contract with...

This is a delivery order contract awarded by the National Center for Advancing Translational Sciences (NCATS), a civilian agency, to CCS Associates, Inc., a woman-owned small business. The $545,690.33 contract is for regulatory activities supporting PCCA and MMAB gene therapy products. The contract has a period of performance through May 20, 2028 and is a labor hours contract type. CCS Associates has previously secured several large Indefinite Delivery Vehicle (IDV) contracts with NCATS, the...

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. Cdisc...

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....