Delivery Order HHSF223201310017I-HHSF22301009T

This is a Definitive Contract awarded by the Food and Drug Administration (FDA), a civilian agency, to the prime contractor Research Triangle Institute (RTI International) on September 27, 2023. The contract has a Firm Fixed Price pricing type and a Ceiling Value of $845,834.00. The contract includes three deliverables: a Literature Review (Deliverable 1), a Qualitative Patient Experience and Preference Study (Deliverable 2), and a Quantitative Patient Preference Study (Deliverable 3). The...

This is a $1,299,218.00 Definitive Contract awarded by the Food and Drug Administration (FDA) to PPD Development LP, a global contract research organization (CRO) and subsidiary of Thermo Fisher Scientific. The contract is for "BAA-FY24C3CP5-UNDERSTANDING HETEROGENEITY IN PREFERENCES FOR CLINICAL TRIAL PARTICIPATION IN DIVERSE PATIENT POPULATIONS" and has a period of performance through February 2, 2026. The contract is a Time and Materials type with no set-aside designation. PPD...

The Department of Health and Human Services Food and Drug Administration awarded a $2,877,830 firm fixed price delivery order contract to Biopharma Services USA Inc. for NASAL PHARMACOKINETIC (PK)PHARMACODYNAMIC (PD) STUDIES OF ORAL COMBINATION PRODUCTS CONTAINING OPIOID AGONISTS AND ANTAGONISTS. As a foreign owned, self-certified small disadvantaged business, Biopharma Services USA will conduct the in vivo study of generic drug products in human subjects to fulfill the FDA's major program of...

This is a definitive contract awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a nonprofit organization, to provide services in support of the agency's Model-Informed Drug Development (MIDD) program for the evaluation and development of neurological drug products. The $1,128,848.00 firm fixed-price contract has an anticipated completion date of August 31, 2023. C-Path has previously supported the FDA's...

The Department of Health and Human Services' Food and Drug Administration (FDA) awarded a $1,275,361.26 definitive cost-no-fee contract to Alliance Nctn Foundation, a non-profit organization and foundation, to conduct the "Integrating Clinical Trials and Real World Endpoints Data (ICAREDATA) Data Capture and Standardization Study". This contract, with a performance period ending on September 29, 2024, is part of the FDA's broader efforts to advance regulatory science and support public...

The Department of Health and Human Services Food and Drug Administration awarded a definitive, cost-no-fee contract to the Alliance Nctn Foundation, a non-profit organization, for the "Adverse Event Reporting in the Integrating Clinical Trials and Real World Endpoints Data (ICAREDATA) Initiative" with a potential value of $518,381.51. The contract, which does not have a set-aside designation, is for work to be performed in Chicago, Illinois and has a completion date of December 31,...

We Pharma, Inc. doing business as WEP Clinical has been awarded a firm fixed price delivery order valued at one hundred thousand dollars from the Department of Health and Human Services' Food and Drug Administration (HHS FDA) to provide currently marketed drug products for FDA research studies. This order was issued against the company's existing five-year, nine and a half million dollar contract awarded in 2020 by HHS FDA to supply drug products for internal research in support of the...

The U.S. Food and Drug Administration (FDA) awarded a $1,845,195.00 firm fixed price delivery order contract to Biopharma Services USA Inc., a foreign-owned small disadvantaged business, to conduct a randomized, open-label, two-treatment, four-period, single-dose, fully replicate, crossover bioequivalence (BE) study of tacrolimus capsules 5 mg. This task order was issued under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract with the ID HHSF223201610004I. The contract has a May 31,...

This is a $1,737,262.53 task order awarded by the Department of Health and Human Services' National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke to PPD Development LP, a global contract research organization (CRO). The task order is for Phase I clinical trials in the development of neurotherapeutics and is part of the larger "Phase I Clinical Trials for Development of Neurotherapeutics" indefinite delivery/indefinite quantity (ID/IQ) contract....

This contract was awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to Eastern Research Group, Inc. (ERG), a for-profit subchapter S corporation. The contract, valued at $296,634.15, is a delivery order under ERG's existing FDA Center for Drug Evaluation and Research (CDER) Priority Analysis multiple-award indefinite-delivery, indefinite-quantity (IDIQ) contract. The work involves research and analysis to support the FDA's regulatory rulemaking efforts...