RECOVERY: "Data Management and Coordinating Center for Phase 2 Trials"

This is a Small Business Sources Sought notice, issued in accordance with FAR 19.202 and HHSAR 319.202-2(a)(1). This is NOT a solicitation for proposals, proposal abstracts, or quotations. 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 relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Responses will assist the Government in selecting the appropriate acquisition mechanism and/or small business set-aside threshold. An organization that is not qualified as a small business under NAICS code 541711 should not submit a response to this notice. Background. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH) is requesting capabilities statements from Small Businesses (including veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns) which demonstrate their capability to provide clinical trial coordination, clinical data management, and regulatory support for a phase 2 multicenter clinical trial to address the present and anticipated future needs of the NIAAA Medication Development Program. Requirements and Tasks. The Contractor would be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, and serve as coordinating center data management center that accomplishes the work described below. In general terms, the contractor would provide resources and services necessary to support a broad range of activities required to effectively manage multicenter (up to six sites) phase 2 clinical trials. This includes multiple activities requiring advanced expertise in the management of clinical trials. Although distinct performance areas have been identified, it is impossible to anticipate every need of the NIAAA, both because the clinical trial and its associated unique demands are unknown, and because of possible unanticipated NIAAA and NIH policy changes. The contractor would provide clinical trials professionals with broad enough expertise to handle such unanticipated needs. It is anticipated that the Contractor would provide the following clinical trial support services: - Clinical trial coordination - Clinical site selection based on criteria specified by NIAAA - Preparation of operations and pharmacy manuals - Preparation of customized database - Preparation of case report forms - Data coordination and quality control - Clinical monitoring - Packaging, shipping and coordination of study medication - Logistical and meeting services - Regulatory support to include preparation of Investigational New Drug (IND) applications, annual reports, and IND amendments - Adverse event and Serious adverse event reporting - Statistical support and data analysis - Final clinical study report preparation. Information Requested: Information should be relevant and specific to the technical area described above, with regard to each of the following qualifications: (1) Experience: An outline of previous work specific to the requirements and tasks listed above; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as principal investigator and other key positions; (3) Facilities: Availability and description of facilities and equipment required to conduct the analyses; and (4) Any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented is desirable. Responses should be limited to 25 pages in font size 10 or larger and shall include the organization's name, address, point of contact, size and type of small business (i.e., small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns) pursuant according to the North American Industrial Classification Code (NAICS) 541711. 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 nor otherwise pay for preparing any information sent or the Government's use of the information. Any proprietary information should be marked as such. Written Capability Statements must be received by the NIAAA Contracting Officer by 5:00 p.m. local time, 25 May 2010. NOTE: See the FBO Special Notice that was posted for this requirement on 12 May 2010 referencing solicitation no. NIAAA-10-04.