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SAMDAILY.US - ISSUE OF NOVEMBER 05, 2020 SAM #6916
SOLICITATION NOTICE

A -- National Cancer Institute, Center for Cancer Research, Sponsor and Regulatory Oversight Support

Notice Date
11/3/2020 11:11:27 AM
 
Notice Type
Solicitation
 
NAICS
541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
 
Contracting Office
NIH National Cancer Institute Rockville MD 20850 USA
 
ZIP Code
20850
 
Solicitation Number
75N91020R00027
 
Response Due
11/24/2020 1:00:00 PM
 
Archive Date
11/24/2021
 
Point of Contact
Paula Wilkison, Phone: (240) 276-7386, Sara McLaurin, Phone: (240) 276-5438
 
E-Mail Address
paula.wilkison@nih.gov, sara.mclaurin@nih.gov
(paula.wilkison@nih.gov, sara.mclaurin@nih.gov)
 
Small Business Set-Aside
SBA Total Small Business Set-Aside (FAR 19.5)
 
Description
The purpose of this acquisition is to provide for clinical trials sponsor and regulatory management support services to the National Cancer Institute (NCI), the Center for Cancer Research (CCR), and CCR investigators. Services shall include compliance with U.S. and international regulations, regulatory support to ensure Food and Drug Administration (FDA) regulation adherence, safety monitoring, oversight and reporting, clinical site assessment and interim monitoring, site essential regulatory documentation, trial master file support, sponsor quality management support, medical writing, administrative support, and computerized activity tracking, monitoring and reporting systems. The Contract shall also support management of multi-center trials in which the CCR is the Sponsor, and in non-CCR sites recruitment and management. Please see the attached Request for Proposal document, ""NCI_SROS_RFP_75N91020R00027"", for additional information and proposal instructions. (PLEASE NOTE:� This RFP will NOT be available at the National Cancer Institute homepage (http://rcb.cancer.gov/rcb-internet/index.jsp.) as indicated in the pre-solicitation notice. ) Submit all questions in writing to: paula.wilkison@nih.gov Responses to questions will be provided in Amendments to the Solicitation. Questions received after 4:00 P.M. Eastern Time on October 30, 2020 may not be addressed. AMENDMENTS: October 5, 2020:� Amendment 1 (see attachment) November 3, 2020:� Amendment 2 (see attachment)
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/c4a25a5d5cfa4bdbace3b89ed188772f/view)
 
Place of Performance
Address: USA
Country: USA
 
Record
SN05844595-F 20201105/201103230140 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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