Purchase Order HHSF223200811298P

Pinnacle 21, LLC was awarded a $223,540 delivery order against its indefinite delivery contract with the Department of Health and Human Services' Food and Drug Administration to provide Automation of Study Data Tabulation Model (SDTM) - Analysis Data Model (ADAM) Content Validation (CASA-CV) services. The prime contractor will perform the work in Penllyn, Pennsylvania through September 2022, utilizing a labor hour pricing structure. Pinnacle 21 is an industry leader in CDISC compliance and...

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...

The Food and Drug Administration awarded a no-cost modification to PPD Development LP on September 24, 2024, to extend the period of performance for BAA-FY24C3CP5, "Understanding Heterogeneity in Preferences for Clinical Trial Participation in Diverse Patient Populations," through April 13, 2026. This Definitive Contract, valued at $1.3M and structured as a Time and Materials engagement, supports FDA's research objectives by examining factors that influence clinical trial enrollment...

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 federal contract award, with an ID of 75F40121D00014|75F40124F19010, was granted by the Food and Drug Administration (FDA) to Pinnacle 21, LLC, a for-profit limited liability company based in Blue Bell, Pennsylvania. The contract, which does not have a set-aside designation, is for the Fiscal Year 2024 automation of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADAM) content validation services in support of the FDA's Center for Biologics Evaluation and Research (CBER). The...

The Emmes Company LLC was awarded a cost-plus-fixed-fee delivery order valued at approximately $687,000 by the National Institutes of Health's National Institute on Drug Abuse to support the Clinical Trials Network's Pharmacist-Integrated Model of Medication Treatment for Opioid Use Disorder clinical trial. The two-year contract will utilize the NIH's DATA, STATISTICS, AND CLINICAL TRIAL SUPPORT CENTER indefinite-delivery/indefinite-quantity vehicle to provide data, statistics, and clinical...

The Defense Health Agency awarded a delivery order valued at $8.9 million to Laulima Government Solutions, LLC for clinical trial support services under a Cost Plus Fixed Fee arrangement. The contract, which commenced on March 22, 2021 and extends through September 30, 2026, provides non-personnel services supporting two research clinical trials. Performance will be executed in Silver Spring, Maryland. This delivery order was awarded without a set-aside designation to Laulima Government...

Technical Resources International, Inc. (TRI), a minority-owned and woman-owned small business based in Bethesda, Maryland, was awarded a delivery order valued at $64,680.72 for Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE) services. The contract, awarded on September 28, 2020, by the Office of the Assistant Secretary for Preparedness and Response (ASPR), consists of both base contract and administrative task order components under a cost-plus fixed fee pricing...

This $1,429,138.43 firm fixed price delivery order was awarded to Spaulding Clinical Research, LLC by the Food and Drug Administration (FDA), a civilian agency of the U.S. government. The delivery order was issued under Spaulding's $30 million Indefinite Delivery Indefinite Quantity (IDIQ) contract with the FDA for clinical and laboratory applied regulatory science services. The delivery order is for clinical electrocardiogram (ECG) studies to evaluate the electrophysiological effects of...

This contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Brillient Corporation, a management, technology, and business process management firm, to provide support services to maintain and update the International Council for Harmonisation (ICH) and FDA's implementation packages to ensure the required documentation is up-to-date as the FDA moves towards formal acceptance of the Electronic Common Technical Document (eCTD) Version 4.0 message....