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

Agency: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time. The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking capability statements from small business organizations (NAICS 541990; small business size standard is $15M) with experience in providing support for medications development. Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol problems. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone. Thus, the search for new molecular targets and more efficacious medications is critical. The creation of the NIAAA's Medications Development program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct clinical trials of promising compounds to treat alcohol problems. This Sources Sought is for 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. Project Requirements Include: 1. Clinical trial study coordination and management 2. Preparation of the study protocol, informed consent forms, and statistical analysis plan 3. Preparation and maintenance of electronic data capture at clinical sites and a compatible, validated clinical data management system. 4. Preparation of case report forms, manual of operations and other study related documents 5. Data coordination, data quality assurance and data quality control 6. GCP clinical monitoring and reporting to NIAAA 7. Packaging, shipping and coordination of study medication 8. Logistical and meeting services 9. Regulatory support to include preparation of Investigation New Drug (IND) applications, annual reports, and other necessary IND submissions 10. Adverse event and Serious adverse event reporting 11. Statistical support and data analysis 12. Final clinical study report preparation 13. Study manuscript preparation Information Requested: 1. Experience: An outline of previous work specific to the requirements and tasks listed above; 2. Personnel: Name, professional qualifications and specific experience of scientist and/or technical personnel who may be assigned as principal investigator and other key positions; and 3. Facilities: Availability and description of facilities and equipment required to conduct the analyses. 4. Other: Any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented is desirable. The Capability Statement Must Demonstrate the Ability to: Small business concerns that possess the capabilities necessary to undertake the efforts should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented. Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer Representative and Contracting Officers. Information Submission Instructions: The offeror shall provide an electronic version only of their response to this notice. Responses shall include the organization's name, address, point of contact, size of business pursuant according to the North American Industrial Classification Code (NAICS) and must address all the technical information requested. The page limit is 15 pages using a font size 10 or larger. Responses will assist the Government in selecting the appropriate acquisition mechanism. Additionally, the response must provide answers to the following questions: 1. Is your organization a small business under NAICS code 541990? 2. Does your firm qualify as a small disadvantaged small business? 3. If disadvantaged, is your firm certified under section 8(a) of the Small Business Act? 4. Are you a certified HUB Zone firm? 5. Are you a woman-owned or operated business? 6. Are you a certified Service-Disabled Veteran Owned or Veteran Owned business? This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a Request for Proposals. The Government DOES NOT intend to award a contract based on responses under this announcement. Interested parties shall not be reimbursed for costs associated with preparation of their responses. Any proprietary information should be so marked. Interested organizations presenting a Capability Statement in response to this Small Business Sources Sought Synopsis must identify their size status. All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NIH-NICHD-2019-01. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 3:00 PM (Eastern Prevailing Time) fifteen (15) calendar days (including date of submission to Fedbizopps) after posting of the Small Business Sources Sought Notice. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.