Cancer Prevention Clinical Trials Auditing and Informatics Support

THE PERIOD OF PERFORMANCE IS CHANGED TO 5 YEARS AND THE DRAFT STATEMENT OF WORK IS UPDATED WITH FORMATTING CHANGES. This is a Small Business Sources Sought notice. 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 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. The NAICS code for this acquisition is 541990 - All Other Professional, Scientific, and Technological Services, which has a size standard of $14,000,000. 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 Cancer Institute, Division of Cancer Prevention (DCP) supports science that seeks to identify those at increased risk for developing cancer, as well as to identify and develop chemopreventive and other interventions to delay, arrest or reverse carcinogenesis at its earliest stages. The Division of Cancer Prevention manages a diverse portfolio of scientific and clinical initiatives in order to identify and prioritize potential cancer prevention agents, and to move these promising agents from pre-clinical testing to Phase 0, Phase I and Phase II clinical trials, and ultimately into large Phase III cancer prevention clinical trials. These clinical trials are conducted by extramural investigators at national and international clinical sites, and are supported through a variety of federal funding mechanisms including grants, cooperative agreements, and contracts. The Division of Cancer Prevention oversees the systematic early clinical development of promising preventive agents through its Phase 0-I-II Cancer Prevention Clinical Trials Program: the Consortia for Early Phase Prevention Trials. First funded in 2003 with a core of six major medical research centers, the Consortia program was renewed in 2012 with five of these major medical research centers chosen to lead studies. Each Consortia organization consists of a Lead Organization and one or more Participating Organizations. Data management, data reporting and auditing requirements for Consortia studies, as well as the training and education needs of Consortia staff, varies based on the requirements of the Consortia funding mechanism. Quality control auditing of the clinical sites for compliance with protocol, policy and regulatory requirements, and verification of data accuracy and quality by DCP assures that DCP's responsibility for oversight of all its sponsored studies is fulfilled. Purpose and Objectives: The National Cancer Institute, Division of Cancer Prevention (DCP) is seeking integrated, comprehensive clinical trial oversight capability for the cancer prevention clinical trials program by providing services required to perform the following tasks: - Task Area 1: Provide services for the data management of designated cancer prevention clinical trials and the development, maintenance and integration of data transfer and reporting mechanisms for data collected from cancer prevention clinical trials. - Task Area 2: Provide auditing and data verification services for cancer prevention clinical trials. - Task Area 3: Provide education and training services to staff conducting cancer prevention clinical trials. Project Requirements: A copy of the draft Statement of Work (SOW) pertaining to this requirement, which is subject to revisions, is attached to this notice. Anticipated Period of Performance: The period of performance for this ID/IQ contract would be 5 years. The anticipated start date is December 16, 2013. A single award is anticipated. Capability Statement/Information Sought: Respondents must be qualified and prepare a capability statement for all Task Areas in the Statement of Work. The Capability Statement will be evaluated based on the information provided in relation to the project requirements and the current capability and capacity to: 1) perform the work in the Task Area (s) in the attached Draft Statement of Work; 2) staff education, training, experience, expertise and knowledge; 3) prior completed projects and Government contracts of similar nature; 4) corporate experience and management capability. Instructions for Submission of Capability Statements: 1. Information Submission Instructions: Interested qualified small business organizations should submit a capability statement, not to exceed 15 total single-spaced pages, double sided (2 sides = 2 pages) using a 12 point font size at a minimum, that clearly details the firms ability to perform and that addresses the specific requirements described above and the draft Statement of Work (SOW). Please provide your DUNS number, organization name, address, point of contact, including names, titles, addresses, telephone, fax numbers, email addresses, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code. 2. Number of Copies/Delivery Point: All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Rachel Weiszer, Contracting Officer at rweiszer@mail.nih.gov either in MS Word, or Adobe Portable Document Format (PDF). The email subject line must specify HHS-NIH-NCI-SBSS-PCPSB-35003-43. Facsimile and telephone responses will not be accepted. 3. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than Wednesday July 3, 2013, 4:00PM EST. CAPABILITY STATEMENT RECEIVED AFTER THAT DATE AND TIME WILL NOT BE CONSIDERED. DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your responses. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).