Purchase Order 75N93018P00724

This federal contract award is for the Clinical Pharmacology Quality Assurance (CPQA) program, which provides comprehensive quality assessment services to clinical pharmacology laboratories testing samples from subjects enrolled in National Institute of Allergy and Infectious Diseases (NIAID)-supported clinical studies. The prime contractor is The Research Foundation For The State University Of New York (RF SUNY), doing business as Sponsored Projects Services. The contract has a ceiling value of...

The Department of Health and Human Services Food and Drug Administration awarded a definitive contract valued at $831,964 to Research Center Pharmaceutical Engineering GmbH. The firm fixed price contract is to provide services in support of the project titled "OCT for Real-Time Monitoring of Coating Process Dynamics & Product Quality" and will involve work by the prime contractor and its parent organization, Technische Universitaet Graz. The contract has a period of performance...

This is a Cost Plus Fixed Fee contract awarded by the Office of the Assistant Secretary for Preparedness and Response (ASPR) to Technical Resources International, Inc. (Technical Resources Intl), a minority-owned, woman-owned, Hispanic American-owned small business. The contract, with a ceiling value of $74,513,740.28, is for Clinical Research Organization (CRO) assistance in support of the ACTIV-1 Master Protocol, a clinical trial initiative. The contract is a Delivery Order under the Medical...

Propharma Group, LLC, doing business as Acadeus, was awarded a firm fixed price blanket purchase agreement (BPA) call contract valued at $1,642,761 by the National Institutes of Health (NIH) Clinical Center to provide expert consultants in reorganization and implementation of a quality unit organization encompassing both quality and regulatory compliance. The NIH Clinical Center Office of Research Support and Compliance has an ongoing need for these services to support restructuring a quality...

This is a firm fixed price delivery order contract awarded by the Department of Health and Human Services Food and Drug Administration (HHS FDA) to The Emmes Company LLC, a for-profit limited liability company, to provide clinical site monitoring services for FDA-funded human subject research studies. The potential value of the contract is $1,391.98 and the period of performance ends on December 5, 2023. The Emmes Company is a global clinical research organization that provides biostatistical,...

The Department of Veterans Affairs Veterans Health Administration awarded a firm fixed price delivery order contract to Shontz Allison, a woman-owned small business limited liability company, to provide auditing, oversight, and quality assurance services in support of the agency's Cooperative Studies Program clinical trials. The delivery order, valued at $342,113.50, was issued under the "Good Clinical Practice Clinical Research Quality Assurance (GCP CRQA)"...

This is a $68,115.00 Firm Fixed Price contract awarded by the Office of the Assistant Secretary for Preparedness and Response, a civilian agency, to Atelerix Life Sciences Inc. for a Phase 1A clinical trial of the novel small molecule ATLX-0199. The objective of the trial is to evaluate the compound in 30 normal healthy subjects. This contract is not set aside and is part of the ATELERIX - PROOF-OF-CONCEPT CLINICAL TRIAL FOR A NOVEL RESPIRATORY STIMULANT major program. The work will be performed...

This is a $5,758,524.34 delivery order contract awarded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to PPD Development LP, a global contract research organization (CRO). The contract is to provide monitoring services for a Phase III clinical trial, specifically trial A5300B/PHOENIX. It is a cost-plus-fixed-fee contract with an ultimate completion date of December 14, 2025. The contract was awarded on April 15, 2019 and is not...

The Department of Health and Human Services' National Institutes of Health's National Institute of Child Health and Human Development awarded a $19,460 firm fixed price purchase order to Amarex Clinical Research, LLC for protocol monitoring and review services. Amarex Clinical Research will deliver these services in Bethesda, Maryland under the contract, which runs from December 3, 2015 through December 20, 2016. No additional details were provided on the original solicitation requirements or...

This federal contract award is for MONITORING SERVICES, valued at $263,356.72, and was awarded to Mary Mills & Associates, LLC, a woman-owned small business. The contract was issued by the Department of Veterans Affairs (VA) and is part of a larger Indefinite Delivery Vehicle (IDV) contract with a ceiling value of $4,400,000, awarded in April 2021 with an ultimate completion date of April 16, 2024. The work primarily involves providing Good Clinical Practice (GCP) Clinical Research Quality...