SOLICITATION NOTICE
R -- Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder Contract Research Organization
- Notice Date
- 11/1/2018
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-2019-01
- Archive Date
- 11/30/2018
- Point of Contact
- Daniel Federline, Phone: (301) 435-6972, Jeremy D. White, Phone: 3014024572
- E-Mail Address
-
daniel.federline@nih.gov, jeremy.white@nih.gov
(daniel.federline@nih.gov, jeremy.white@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT November 15, 2018. The National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) is planning to issue an RFP for a contract for the Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder - Contract Research Organization. This will be a 100% Set-Aside for Small Business. This acquisition is for a new requirement and is anticipated to be for an indefinite delivery indefinite quantity (IDIQ) type contract. The contractor will serve as a Contract Research Organization (CRO) for the Division of Medications Development (DMD) Extramural Clinical Program. The Contractor shall serve as the CRO to conduct all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). The CRO will develop and have the overall responsibility for the operation of the clinical trial including but not limited to; clinical trial coordination, clinical site oversight and management, preparation of study documents, electronic data capture capabilities, Good Clinical Practice (GCP) monitoring services, acquisition and facilitation of packaging, shipping and coordination of study medication, logistical and meeting services, regulatory support and services, statistical and data analysis, and final clinical study report preparation and manuscript preparation. It is anticipated that 4-6 trials will be completed during the life of the contract. Conduct of the trials will be monitored by an independent Data and Safety Monitoring Board (DSMB) chosen by and reporting to the NIAAA. The CRO will consult regularly with the DMD staff at NIAAA to establish research priorities and provide on-going updates on the status of the trial(s). Studies conducted in association with this program are expected to emphasize treatment of AUD with novel or repurposed compounds. The RFP will be made available electronically via the FedBizOpps website (https://www.fbo.gov). Offerors are responsible for routinely checking the FedBizOpps website for any possible solicitation amendments that may be issued. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. It is the Offerors responsibility to monitor FedBizOpps at https://www.fbo.gov for the release of the solicitation and any amendments.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-2019-01/listing.html)
- Place of Performance
- Address: National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN05140627-W 20181103/181101230801-14408ec010911a2caeb57d3fea651c7e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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