Medications Development Clinical Trials Network for the Treatment of Alcohol Use Disorder Contract Research Organization

THIS IS A REQUEST FOR PROPOSALS (RFP). This notice is related to Sources Sought Notice NIH-NICHD-2019-01, released on June 7, 2018. The Pre-Solicitation Notice was released on November 1, 2018. This acquisition is for a new requirement and is 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. This procurement is restricted to small businesses. Only small businesses eligible under North American Industry Classification System (NAICS) code 541990, titled: All other Professional, Scientific and Technical Services, and with a small business standard size of $15 million may submit a proposal. This RFP will only be available via the internet at the above website. Potential Offerors are responsible for accessing the website. Interested parties must respond to the solicitation in order to be considered for award of any resultant contract. There is no written solicitation available, telephone requests will not be honored, and no bidders list will be maintained. Potential Offerors are required to direct all questions via e-mail to the primary or secondary points of contact on this notice. Offerors are responsible for routinely checking FedBizOpps website for any possible solicitation amendments that may be issued.