Inactive Total Small Business Set-Aside (FAR 19.5)

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 concentration... 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.