National Cancer Institute, Center for Cancer Research, Sponsor and Regulatory Oversight Support
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- 75N91020R00027
- Agency
-
National Cancer Institute
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- USA
Notice details come from SAM.gov. Updated .
About this opportunity
The National Cancer Institute, Center for Cancer Research seeks proposals to provide clinical trials sponsor and regulatory oversight support services through November 24, 2020. Services include FDA and international regulatory compliance, safety monitoring, site assessments, trial master file support, quality management, medical writing, and computerized tracking systems. Proposals will be evaluated based on technical approach, management approach, past performance, and price/cost. Amendments provide additional details and extend the period of performance to ten years.
This requirement is set aside for small businesses and concerns clinical research support services. The NAICS code is 541715 and PSC code is R425. Performance will be located throughout the United States to support management of NCI-led multi-center trials and non-NCI site recruitment. The anticipated award is a cost-plus-fixed-fee contract for up to ten years to one or more small businesses to provide regulatory and administrative services for NCI's clinical research programs.
Notice text
3 versions
Update #3 · Latest ·
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)
Update #2 ·
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)
Update #1 ·
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. )
Files
| File | Type | Posted |
|---|---|---|
| 75N91020R00027_amendment 2.pdf | ||
| 75N91020R00027_amendment 1.pdf | ||
| NCI_SROS_RFP_75N91020R00027.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| National Cancer Institute, Center for Cancer Research, Sponsor and Regulatory Oversight Support | Award Notice | |
| This notice | Solicitation | |
| National Cancer Institute, Center for Cancer Research, Sponsor and Regulatory Oversight Support | Pre-Solicitation |
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