SOLICITATION NOTICE
R -- Clinical ECG Study - FA-SOL-16-1165826
- Notice Date
- 6/20/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-16-1165826
- Archive Date
- 7/21/2016
- Point of Contact
- nicola l camichael, Phone: 3018270109
- E-Mail Address
-
nicola.carmichael@fda.hhs.gov
(nicola.carmichael@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The objective of this contract is to execute a double-blind, randomized, single-period, parallel-arm study in 70 healthy subjects with six different drugs and placebo. Each of the 70 subjects shall visit the clinic for 1 period and consisting of 3 consecutive dosing days, during which the subjects must remain in the study unit. Additional details on the study are included in attachment A. The contractor shall collect continuous 12-lead ECG Holter recordings and pharmacokinetic (PK) blood samples, as well as complete other aspects of the study outlined below. Of note, the contractor is not required to perform ECG core lab analysis, analyze PK samples or perform statistical analysis.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-16-1165826/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04155127-W 20160622/160620234222-1d588270e8492218ea458bb4b9778c26 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |