Statistical and Clinical Coordinating Centers for the NICHD Contraceptive Clinical Trials Network

Description 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 serve as Statistical and Clinical Coordinating Centers (SCCC) for the NICHD Contraceptive Clinical Trials Network (CCTN) in coordinating, monitoring and supporting large scale, multi-site Phase I, II, III and IV contraceptive trials designed to evaluate systematically the safety and efficacy of candidate drugs and devices. 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), Premarket notification 510k, Premarket Approval (PMA) or Investigational Device Exemptions (IDE). 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 Contraceptive and Reproductive Health Branch's 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 will be evaluated against the following technical areas of experience and expertise: 1. The qualifications and abilities of the organization's staff in the coordination and monitoring of large scale, multi-site Phase I, II, III, and IV contraceptive clinical trials designed to evaluate systematically the safety and efficacy of candidate drugs and devices for advancing them through development with the ultimate goal of submission to the FDA in support of an New Drug Application (NDA), Premarket notification 510k, Premarket Approval (PMA) or Investigational Device Exemptions (IDE). Demonstrate experience of proposed staff in the development of research protocols, onsite monitoring of clinical trials, and the statistical analysis of data from these trials. 2. The organization's experience and ability to implement a quality control system for monitoring clinical, laboratory, and data collection procedures, with timely feedback to the individual clinical sites. Demonstrate experience and ability to implement an on-line web based (or at a minimum web enabled) data management system for collection, checking, editing, analyzing and correcting data from individual sites. 3. The organization's experience and availability of necessary personnel to participate in protocol review, protocol development, logistical support for meetings and conference calls, advise the CCTN Scientific Advisory Committee (SAC), and ancillary services in support of contraceptive clinical trials. 4. Demonstration of well designed procedures for the provision of field management support to the trial sites designed to ensure high-quality data, protection of participants' confidentiality, and data security. Plans for training field site personnel, development of participant registration and randomization schemes, case report forms development, tracking of subjects from sites, adverse event reporting, development of Investigator's Handbook and Manual of Operations will be evaluated. 5. 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. The experience of the organization with respect to similar projects. Identify project dates and sponsors, specific responsibilities with respect to these projects, the type of personnel allocated and their respective level of effort, accomplishments, and evidence of meeting performance objectives in submitting deliverables on schedule. 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 no later than 4:00PM local time on November 7, 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. INQUIRIES: David Fitton, Contract Specialist Eunice Kennedy Shriver National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A-07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-5239 Fax: (301) 402-3676 E-mail: david.fitton@nih.gov OR Ross Kelley, Contracting Officer Eunice Kennedy Shriver National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 7A07, MSC 7510 Bethesda MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-435-6960 Fax: 301-402-3676 E-mail: rk17a@nih.gov