Contraceptive Clinical Trails in Females

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, SDB, 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 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees or less. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)/NIH, seeks capability statements from interested and qualified potential sources to conduct Phase I, II, III and IV contraceptive trials in females, and treatment trials for gynecologic conditions such as endometriosis or leiomyomata, and development of research protocols on a task order basis. The results of these clinical trials would be the bases for advancing candidate drugs and devices through development with the ultimate goal of submission to the FDA in support of a New Drug Application (NDA). The NICHD Contraception and Reproductive Health Branch (CRHB) has long supported several pre-clinical contraceptive testing facilities, as well as facilities for chemical and peptide synthesis. To further expand their contraceptive development capabilities, in 1996 CRHB established the NICHD Contraceptive Clinical Trials Network (CCTN), which initially consisted of nine sites, in order to conduct clinical trials of new contraceptive methods. The CCTN is an important component of the CRHB contraceptive development capability. Products that have undergone formulation and successful pre-clinical testing, either through CRHB formulation and testing facilities or through outside sources, are candidates for clinical testing in the CCTN. The CCTN is particularly valuable for providing a venue for testing new contraceptive drugs and devices that have been developed by small companies that lack the resources to support large-scale clinical 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 female contraceptive research. 3. 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. 4. 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. 5. Experience with respect to similar projects, including project dates and sponsors, specific responsibilities with respect to these projects. 6. Ability to serve as a repository for biological samples and clinical data. Interested organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies in addition to four (4) hard 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. Written capability statements should be received by the Contract Specialist by no later than 4:00PM local time on October 31, 2011. 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). NO COLLECT CALLS WILL BE ACCEPTED.