Definitive Contract HHSF223201510133C

The Department of Health and Human Services Food and Drug Administration awarded a $2.3 million firm fixed-price contract to Clarivate Analytics (Us) LLC for Biomarker Database Search Solutions supporting and enhancing biomarker qualification. The five-year contract provides continuous access to a well-curated biomarker database and search capabilities to evaluate biomarker drug development tool submissions as requested in the solicitation. Clarivate Analytics will deliver its biomarker...

This is a $787,013 cost-reimbursement contract awarded by the Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a non-profit organization, for the "Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers." The contract, which does not have a set-aside designation, was awarded on September 8, 2016 and has a completion date of June 29, 2019. C-Path's work under this contract involves collaborating with industry, academia, and patient...

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...

This federal contract award, valued at $480,183.00, was made by the Food and Drug Administration (FDA) to Idaho State University to conduct research and development to understand patient information needs and the factors that influence patients' perceived value and trust of healthcare artificial intelligence (AI) applications. The goal is to develop guidance for the FDA and device manufacturers to ensure information is appropriate, transparent, and supports informed decision-making. The contract...

The Food and Drug Administration (FDA) awarded a $94,500 firm fixed-price purchase order to Olink Proteomics AB, a foreign-owned manufacturer of protein biomarker analysis technologies and services. The contract is for quantitative proteomics measurement of cardiotoxicity biomarkers in 150 human plasma samples using Olink's proprietary Explore 1536 multiplex analysis platform. This purchase order was awarded without a set-aside and is not associated with a larger contract vehicle. Olink...

This federal contract award is for $4,418,256.96 to The Critical Path Institute (C-Path), a non-profit organization, by the Food and Drug Administration (FDA). The contract was awarded under the FDA's Broad Agency Announcement (BAA) EETWP #63 to develop "A STANDARDIZED FRAMEWORK TO SUPPORT FDA QUALIFICATION OF COMPLEX IN VITRO MODELS FOR USE IN REGULATORY SUBMISSIONS." The BAA solicits research and development proposals to advance regulatory science in various areas of interest for...

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...

This is a definitive contract awarded by the Food and Drug Administration (FDA) to Northwestern University, a private research university, for a study on the influence of brand principle display panels (PDPs) on the safe consumer use of over-the-counter (OTC) drugs. The $286,937 firm fixed-price contract has a performance period ending on December 31, 2018. The study involves conducting mixed-methods research to understand how brand image, familiarity, and display panel labeling impact...

This is a Firm Fixed Price contract awarded by the U.S. Department of Health and Human Services Food and Drug Administration (FDA) to Research Triangle Institute (RTI) International, a non-profit research organization. The $526,321.00 contract was awarded on July 16, 2019 under the FDA's Mission Oriented Business Integrated Services (MOBIS) federal contract vehicle, and the work is scheduled for completion on February 3, 2024. The contract is for "Targeted Mechanism of Action Claims in...

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,...