Definitive Contract W81XWH10C0004

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,...

This is a $2,054,175.16 federal contract awarded by the Centers for Disease Control and Prevention (CDC) to PPD Development LP, a global contract research organization (CRO), for monitoring services in support of the Tuberculosis Trials Consortium (TBTC). The contract is a 5-year definitive contract with a time and materials pricing type. It will involve on-site monitoring, quality assurance, investigational product management, and reporting for TBTC clinical trials of new drugs, diagnostics,...

This is a $36,506,288.06 cost-plus-fixed-fee contract awarded by the National Cancer Institute (NCI) to Theradex Systems, Inc. for clinical trials monitoring services. The contract has a performance period from May 1, 2017 to April 30, 2022. The contract supports NCI's Experimental Therapeutics Clinical Trials Network (ETCTN), National Clinical Trials Network (NCTN), and National Community Oncology Research Program (NCORP), as well as the NCI COVID-19 in Cancer Patients Study (NCCAPS) and the...

This firm fixed-price purchase order for $86,631 was awarded by the Department of Health and Human Services' National Institutes of Health National Cancer Institute to Labcorp Early Development Laboratories Inc. to perform 60-month stability testing of two lots of LMB-100 drug product. LMB-100 is an anti-mesothelin immunotoxin under clinical trials for certain cancers. The prime contractor Labcorp will conduct a battery of assays to ensure the identity, potency, and safety of the drug product...

Comprehensive Research Solutions LLC has been awarded a firm fixed price purchase order valued at $841,363.15 by the National Institutes of Health's National Heart, Lung and Blood Institute to provide clinical research monitoring support services. The contract supports the NHLBI Division of Intramural Research Clinical Research Monitoring program and will be performed in Bethesda, Maryland over a 10-month period concluding in May 2022. No subcontractors or set aside designations were...

This is a $186,449,775.00 cost-plus-fixed-fee delivery order contract awarded by the National Institute of Allergy and Infectious Diseases (NIAID), a civilian agency, to PPD Development LP, a global contract research organization (CRO) and subsidiary of Thermo Fisher Scientific. The contract, titled "NIAID CLINICAL SITE MONITORING (NCSM)", is for clinical site monitoring services with a period of performance through January 31, 2031. This award is under NIAID's $999 million OASIS+...

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...

This is a firm fixed-price delivery order contract awarded by the Food and Drug Administration (FDA) to The Emmes Company LLC, a global clinical research organization, for clinical site monitoring services in human subjects research. The $10,805.70 contract has a performance period through September 15, 2023 and is not set aside for a specific business type. The Emmes Company LLC is an experienced provider of clinical research services to federal agencies, particularly the National Institutes of...

This is a firm fixed-price delivery order contract awarded by the Northeast Area division of a civilian federal agency to Labcorp Early Development Laboratories Inc., a subsidiary of Laboratory Corporation of America Holdings. The $94,239.14 contract is for the provision of laboratory testing and analytical services, including stability testing, potency and safety assays, polyclonal antibody production, pharmacokinetics testing, compositional analysis, and other services to support the work of...

The Department of Health and Human Services Food and Drug Administration awarded a firm fixed price delivery order potentially valued at $14,160.03 to The Emmes Company LLC. The order is for clinical site monitoring in human subjects in St. Louis, Missouri, with a completion date of September 22, 2022. No set-aside designation was used for this award. The Emmes Company will perform the requested clinical site monitoring services under the agency's major program code for Clinical Site Monitoring....