Request for Proposals - Phase I Clinical Trials
Closed Solicitation Posted
- Solicitation number
- 75N95024R00086
- Agency
- National Institute on Drug Abuse National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
-
- Feely, Evan C evan.feely@nih.gov (301) 827-5301
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) is seeking proposals for indefinite delivery, indefinite quantity (IDIQ) contracts to provide full-service, turn-key Phase I clinical trials operations and facilities for the development of novel small molecule and biologic therapeutics. The key objectives are to support Phase I clinical trials of investigational agents developed by NIH and its partners, including agents from various NIH initiatives. Offerors must demonstrate capabilities to conduct Phase I trials in compliance with FDA regulations, including protocol development, trial preparation, clinical implementation, data management, and reporting. The evaluation will assess the offeror's technical approach, key personnel qualifications, facilities and resources, project management, and cost proposal.
The solicitation is unrestricted, with no set-asides. The current incumbents are Duke University and PPD Development. The total ordering period is 10 years, with an anticipated maximum ordering value of $233,227,446. The contracts will have a guaranteed minimum of $10,000 each. Task orders may be issued on a cost-reimbursement, fixed-price, or hybrid basis. The period of performance for the resulting contracts is April 1, 2025 to March 31, 2035. Proposals are due by October 11, 2024.
Notice text
3 versions
Update #3 · Latest ·
Amendment 0003: The attached amendment provides responses to additional vendor-submitted questions.
Amendment 0002: The attached amendment provides responses to vendor-submitted questions; revises the RFP document and RFP Attachments 9 and 10 (Sample Task Order #2 and #3 SOWs); and extends the response deadline to 10/11/2024 at 5 pm ET.
Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics
Update #2 ·
Amendment 0002: The attached amendment provides responses to vendor-submitted questions; revises the RFP document and RFP Attachments 9 and 10 (Sample Task Order #2 and #3 SOWs); and extends the response deadline to 10/11/2024 at 5 pm ET.
Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics
Update #1 ·
Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics
Attachments
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Notice history
| Notice | Type | Posted |
|---|---|---|
| Request for Proposals - Phase I Clinical Trials | Solicitation | |
| Phase I Clinical Trials for Development of Neurotherapeutics | Pre-Solicitation |
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