FFP - single award IDIQ - cder - office of clinical pharmacology clinical studies and laboratory support
Active Indefinite Delivery Contract Awarded Last action
- Contract number
- 75F40125D00003
- Awardee
-
Tranquil Clinical And Research Consulting Services LLC UEI FWWJT8QCEDY4
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Task orders
- 3 $4,114,632 obligated
Award facts
- Opportunity
-
- Food and Drug Administration (FDA) Office of Clinical Pharmacology (OCP) – Multi-phase/Multi- site Clinical Studies and Laboratory Support Indefinite Delivery-Indefinite Quantity (IDIQ) Type Contract Pre-Solicitation · 75F40124R00064 · Posted Jan 18, 2024
- Combined order value
-
- $4,114,632 Current, with exercised options
- $4,990,743 Potential, with all options
- Last date to order 23% complete
- IDV ceiling 8% used
- $50,000,000.00
- Maximum order
- $49,997,500.00
- Award type
- Single award
- Who can order
- Only the awarding agency
- Contracting staff
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- AJ12 General Science And Technology R&D Services; General Science And Technology; Applied Research
- Set-aside
- Total Small Business
- Competition
- Full and Open Competition after exclusion of sources · 3 offers Negotiated Proposal / Quote
- Pricing
- Firm Fixed Price
- Legislative mandates
-
- Service Contract Act FAR subpart 22.10
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
About this IDV
Tranquil Clinical and Research Consulting Services LLC was awarded a single-award Indefinite Delivery Indefinite Quantity (IDIQ) contract by the Food and Drug Administration (FDA) on September 15, 2025, to provide clinical trial and laboratory support services to the Office of Clinical Pharmacology. The contract has a ceiling value of $50,000,000 with an ultimate completion date of September 18, 2030, and is set aside for small businesses. The scope of services encompasses protocol development, clinical trial execution, bioanalytical testing, and supportive laboratory studies designed to advance regulatory science. Task orders issued under this contract are expected to range from one to five years in duration, with the contractor required to demonstrate capability to conduct multiple clinical trials simultaneously while maintaining full compliance with FDA regulations and International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines.
The original pre-solicitation notice was posted on January 18, 2024, seeking capabilities information from small businesses before formal solicitation. The primary classification for this procurement is NAICS code 541714 (research and development in biotechnology), with a size standard of 1,000 employees, and the Procurement Schedule Code is AJ12 for general science and technology research and development services. Under the terms of this IDIQ contract, a portion of minimum guarantee reserved funds has been designated for the award kick-off meeting to initiate contract performance. The contractor must be capable of providing integrated clinical and laboratory support services that support the FDA's mission in regulatory science and drug development evaluation.
Task orders
| Task order | Ordering agency | Obligated | Awarded |
|---|---|---|---|
| FFP task order for proton pump inhibitor PK study for the FDA's center for drug evaluation and research (CDER)… | Food and Drug Administration | $1,227,674 | |
| DDI clinical pharmacology study | Food and Drug Administration | $1,592,481 | |
| Sunscreen absorption clinical pharmacology study | Food and Drug Administration | $1,294,478 |
Transactions
| Action | Obligated | Date |
|---|---|---|
| Supplemental Agreement for work within scope | $0 | |
| Original award | $2,500 |
Quick answers
Who was awarded contract 75F40125D00003?
75F40125D00003 was awarded to Tranquil Clinical And Research Consulting Services LLC by Food and Drug Administration (Department of Health and Human Services) on September 15, 2025.
How much is contract 75F40125D00003 worth?
Orders under 75F40125D00003 have obligated $4,114,632. Their combined potential value, with all options, is $4,990,743. 75F40125D00003's own ceiling is $50,000,000. A single order can be worth up to $49,997,500.
How many orders have been placed under contract 75F40125D00003?
3 orders have been placed under 75F40125D00003, the latest on September 30, 2026.
Who can order from contract 75F40125D00003?
75F40125D00003 is a single award indefinite delivery contract. Only the awarding agency can place orders on it.
Was contract 75F40125D00003 competed?
The extent of competition for 75F40125D00003 was full and open competition after exclusion of sources. The government received 3 offers. It was set aside: Total Small Business.
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