This is a $1,130,545.46 firm fixed-price contract awarded by the Food and Drug Administration (FDA) to Icon Clinical Research LLC, a global provider of outsourced clinical development services. The contract is titled "Evaluation of the Measurement Properties of Patient-Reported Outcome (PRO) Instruments in Patients with Community-Acquired Bacterial Pneumonia (CABP), Hospital-Acquired Bacterial Pneumonia (HABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI)" and has a...
The U.S. Food and Drug Administration (FDA) awarded a $10,128.27 Firm Fixed Price purchase order contract to Hermes Medical Solutions Inc., a foreign-owned for-profit company, for an OLINDA/EXM concurrent software license. This will enable the installation of the OLINDA/EXM medical imaging analysis software on an OCP scientific workstation so that reviewers from the FDA's Center for Drugs Evaluation and Research (CDER) can use it to evaluate radiotherapeutic products. Hermes Medical Solutions...
This is a $845,852.26 firm fixed-price purchase order contract awarded by the Food and Drug Administration (FDA) to Certara USA Inc. for the licensing of the company's CDER CERTARA PHOENIX software products. The award is not associated with a set-aside program and is intended to provide the FDA's Office of Clinical Pharmacology with necessary software tools, including Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator, to support the review of Investigational New Drug (IND), New Drug...
The Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases awarded a firm fixed price purchase order to DXC Technology Company for $57,351.36. The contract is for the procurement of DXC Toolbox Pharma Edition software licenses and annual maintenance to replace expiring verification software and enable continued review of electronic submissions to the FDA for investigational new drugs and drug master files. Specifically, DXC...
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 Department of Health and Human Services' Food and Drug Administration awarded a $157,134 firm fixed price delivery order contract to Regan Technologies Corporation. This order is placed against Solutions for Enterprise-Wide Procurement V, a government-wide acquisition contract vehicle, to provide CLC BIO software licenses. The place of performance is Silver Spring, Maryland. The one-year contract begins on September 27, 2023 and concludes on September 29, 2024. As the FDA works to protect...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $435,003.14 delivery order contract to Iqvia Government Solutions Inc. under the Chief Information Officer Commodities and Solutions (CIO-CS) Government-Wide Acquisition Contract (GWAC) master contract. The contract is for the provision of Linguamatics Natural Language Processing (NLP) Platform software to the HHS FDA. The period of performance is from September 28, 2022 through September 28, 2023. The...
This firm-fixed price purchase order contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Certara UK LIMITED, doing business as Certara, a for-profit limited liability company. The $164,400 contract provides annual licenses and maintenance support for Certara's SIMCYP physiologically-based pharmacokinetic modeling software. The software is used by the FDA's Office of Clinical Pharmacology to review submissions from pharmaceutical sponsors,...
<p>The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a firm fixed-price purchase order contract to Imedris Data Corporation, a for-profit small business, to provide a commercial software program. The contract has a potential value of $183,750.00 and a completion date of December 23, 2023. The contract is set aside for small businesses.</p>
The National Institute of Allergy and Infectious Diseases (NIAID), a civilian agency within the U.S. Department of Health and Human Services (HHS), awarded a $41,198.99 firm fixed price delivery order to Pinnacle 21, LLC for an annual license and maintenance of the Pinnacle 21 Enterprise OpenCDISC Validator software. This software is used by the U.S. Food and Drug Administration (FDA) to review submissions. Pinnacle 21 has previously performed various IT services as a prime contractor for HHS...