Contract Research Organization for the National In

Solicitation description

The Solicitation is amended to provide answers to questions received from potential offerors. Questions and Answers are provided in the 6-page attachment entitled "Amendment 0001 Questions and Answers RFP 75N94025R00008". Additionally, Section L Technical Proposal Instructions, item d. "Enhancing Reproducibility through Rigor and Transparency" (page 108 of RFP) is amended to add previously missing specification language to provide guidance to offerors on how to address this item in their Technical Proposals. See the attachment "Amendment 0001 Questions and Answers RFP 75N94025R00008", question number 6), for full details. FULL TITLE: Contract Research Organization for the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Medications Development Clinical Trials Network This solicitation is issued by the National Institutes of Health, Office of the Director, Office of Acquisitions and Logistics Management, on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). This acquisition is a re-competition for a follow-on contract for Clinical Research Organization (CRO) clinical trial coordination and support services to support all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). This acquisition represents is a follow-on requirement to indefinite delivery/indefinite quantity contract 75N94019D00001, awarded to Fast-Track Drugs & Biologics, LLC with a Task Order ordering period of February 1, 2019 through January 31, 2026. An indefinite delivery/indefinite quantity (IDIQ) contract with an ordering period of seven years (commencing 11/15/2026) for the issuance of project-specific task orders is anticipated to continue the CRO R&D clinical study coordination and support services currently provided under contract 75N94019D00001 for the NIAAA Medications Development Clinical Trials Network. Individual task orders for assigned clinical trials will be issued as needs arise on a cost plus fixed fee basis. The CRO contractor shall support development, coordination and operation of each task order-assigned clinical trial including but not limited to clinical trial coordination support, clinical site oversight and management support, preparation of study documents, electronic data capture of clinical data from all participating clinical sites, Good Clinical Practice (GCP) monitoring services, acquisition and facilitation of study medication and 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 submission and manuscript preparation. The clinical research sites for each assigned task order/clinical study will be established under separate NIAAA contracts. It is anticipated that four to six CRO Clinical Study Support task orders will be issued via individual task orders during the seven-year ordering period of the...

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