Contraceptive Clinical Trials Network Male Sites

This is a Small Business Sources Sought. This is NOT a Request for Proposals (RFP) and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this synopsis is to identify small business organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement this acquisition may be solicited as a 100% small business set-aside. All small business organizations (SB, SOB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541714 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1,000 employees or less. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), seeks capability statements from interested and qualified potential sources to continue with a network of clinical research sites collaborating to evaluate new male contraceptive drugs and devices for safety and efficacy in phase I, II, and potentially phase III clinical trials. This contract will provide the requisite personnel, facilities and services to conduct and support these clinical trials. The data collected from the Contraceptive Clinical Trials Network (CCTN) through clinical trials on new entities are the basis for advancing candidate drugs and devices through development with the ultimate goal of submission to the Food and Drug Administration (FDA) in support of regulatory approval. Products evaluated in the CCTN are selected to address gaps in available contraceptive technology, including the development of methods for men. The Contractor will work with NICHD and the CCTN Statistical and Clinical Coordinating Center (SCCC) to rapidly develop protocols and initiate clinical trials shortly after candidate products have completed the necessary preclinical testing. The CCTN site contractors will evaluate systematically the safety and efficacy of new contraceptive products in phase I, II, and possibly phase III trials. Organizations that submit capability statements in response to this notice must demonstrate and document: 1. The qualifications and experience of the institution's staff to organize and manage clinical trials as well as the ability to recruit and retain subjects. 2. Experience in male contraceptive research. 3. Demonstrated experience of the proposed staff in the development of research protocols for evaluating potential contraceptive products. 4. Experience in conducting clinical trials in compliance with a) Good Clinical Practice and FDA guidelines for the conduct of clinical trials; b) the overall clinical trials process; c) the data acquisition, data monitoring and data management processes; d) protection of patient confidentiality and data security; and e) tracking of pregnancy outcomes. 5. Experience with the development and implementation of a detailed management plan organizing the work, including staff hours or days planned per task and scheduling of deliverables that is reasonable and timely. 6. Experience with similar projects, including project dates and sponsors, specific responsibilities with respect to these projects. 7. Ability to serve as a repository for biological samples and clinical data. 8. Capability to conduct Pharmacokinetic studies (generally conducted in clinic with overnight stay). Interested organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies of their capability statement, addressing the areas above. Please limit responses to fifteen (15) pages or less, excluding resumes. Any proprietary information should be so marked. Electronic capability statements should be received by email to the Contract Specialist by no later than 3:00 PM local time on July 26, 2019. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8 (a), or other corporate or non -corporate entity).