Purchase Order 75F40122P00489

This federal contract award is for a software upgrade and annual maintenance services for the FDA's SEND Explorer Warehouse system. The contract was awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to the prime contractor Integrated Nonclinical Development Solutions Inc. (IND Solutions), a technology-enabled drug development and drug safety consultancy. The contract has a potential value of $257,000.00 and does not use a set-aside designation. The...

The U.S. Department of Health and Human Services' Food and Drug Administration awarded a $3.96 million firm fixed price definitive contract to CWC Group LLC to provide quality management information system software and services in support of the Center for Drug Evaluation and Research. To be performed in Silver Spring, Maryland over a four year period through September 2024, this contract calls for CWC Group to deliver its quality management information solutions and associated services under an...

The Food and Drug Administration awarded a $1.13 million Delivery Order to International Business Machines Corporation (IBM) on September 10, 2025, to establish a centralized hub providing information resources, training, and analytical support for Center for Drug Evaluation and Research (CDER) reviewers utilizing OCS (Office of Computational Science) tools and services. This Delivery Order, which operates under the Multiple Award Schedule (MAS) vehicle, carries a firm fixed price structure with...

This is a $740,907.38 firm fixed price delivery order awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Integrated Clinical Systems, Inc., a for-profit Subchapter S corporation. The contract provides JReview software licensing, maintenance, and technical support services to the FDA's Center for Drug Evaluation and Research (CDER) to support pre-market drug application reviews. Integrated Clinical Systems has previously provided similar services to the...

The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a firm-fixed-price purchase order contract to Integrated Nonclinical Development Solutions Inc. (IND Solutions), a small business, for FY20 Annual SEND Explorer Warehouse and Technical Support. The contract has a potential value of $179,000.00 and a period of performance from August 1, 2020 to July 31, 2021. This contract was awarded under a total small business set-aside. IND Solutions, a...

This is a $11,802,344.74 delivery order contract awarded by the Department of Health and Human Services' Food and Drug Administration (HHS FDA) to Deloitte Consulting LLP, doing business as Deloitte, to provide enterprise data architecture and regulatory review support services for the Center for Drug Evaluation and Research (CDER). The contract is under the GSA IT Schedule 70 program and does not have a set-aside designation. Key subcontractors include Executive Information Systems LLC for...

The U.S. Food and Drug Administration (FDA) awarded a firm fixed price purchase order to Certara UK Limited, doing business as Certara, a for-profit limited liability company, for SIMCYP software licenses and maintenance support. The $114,316.00 contract will allow the FDA's Office of Clinical Pharmacology Drug Reviewers to complete their review of investigational new drugs. Certara has previously provided this physiologically-based pharmacokinetic modeling software to the FDA and...

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Office of Computational Science (OCS) awarded a definitive labor hour contract to Accel Solutions, LLC on September 12, 2022, with a ceiling value of $3.21 million and an ultimate completion date of September 25, 2024. The contract does not utilize a set-aside designation. Accel Solutions, LLC, an SBA-certified economically disadvantaged women-owned small business and 8A Program participant, will provide...

This is a firm-fixed price delivery order awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Carahsoft Technology Corp under the Solutions for Enterprise Wide Procurement (SEWP) V government-wide acquisition contract. The $124,845.55 contract is for a subscription to the FDA's CDER (Center for Drug Evaluation and Research) S-DOC software license. Carahsoft, a large government IT solutions provider, will deliver the software and related services to...

The U.S. Food and Drug Administration (FDA) awarded a 2-year, $4,499,944.46 Firm Fixed Price (FFP) purchase order to Agisol LLC, an SBA-certified 8(a) and Economically Disadvantaged Women-Owned Small Business (EDWOSB), to provide business process user support for the Center for Drug Evaluation and Research (CDER). This contract, which is not set aside, supports critical regulatory review and drug safety activities within CDER. Agisol LLC is a specialized IT services provider that has secured...