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SAMDAILY.US - ISSUE OF MAY 06, 2021 SAM #7096
SOURCES SOUGHT

A -- Multiphase Clinical Studies and Laboratory Support IDIQ

Notice Date

5/4/2021 2:06:28 PM
 

Notice Type

Sources Sought
 

NAICS

541714 — Research and Development in Biotechnology (except Nanobiotechnology)
 

Contracting Office

FDA CENTER FOR DRUG EVALUATION AND RESEARCH Silver Spring MD 20993 USA
 

ZIP Code

20993
 

Solicitation Number

FDARFI1238699
 

Response Due

5/18/2021 11:00:00 AM
 

Archive Date

06/02/2021
 

Point of Contact

Howard S. Yablon, Phone: 2404027630
 

E-Mail Address

howard.yablon@fda.hhs.gov
(howard.yablon@fda.hhs.gov)
 

Small Business Set-Aside

SBA Total Small Business Set-Aside (FAR 19.5)
 

Description

The FDA has the need for Phase I-type clinical trial operations. Depending on the project, the clinical trials under this contract may include assessment of different drug and metabolite concentrations, biomarkers levels, or include novel experimental methodologies. The clinical trials may require enrollment of different subjects depending on the research topic (e.g. target populations may be healthy volunteers, demographic subsets of healthy volunteers, or subjects with conditions of interest) as well as allow for single or multiple dose administration of different drug or biologic products (e.g. small molecules, peptides, proteins or oligonucleotides). �The clinical trials may also require multiple sites to ensure timely enrollment and study completion.��� The FDA also requires execution of supportive laboratory studies related to bioanalytical/biomarker/omics (omics refers to range of techniques for characterization and quantification of biologic molecules).� These assessments may be needed for samples collected from within the clinical trial or could be required as a standalone option for mission-critical needs. The results of studies and other performed work under this contract will be used to advance regulatory science. Overall, the efforts would support a full range of services from clinical trial protocol development, clinical trial execution, conducting supportive laboratory studies, and bioanalytical/biomarker/omics services, where required. See attachments for Sources Sought Document and Draft Statement of Work.
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/c1636f33a3354e80b0bc3d6aebf5aa0d/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN05991361-F 20210506/210504230117 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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