Clinical Research Operations Core

The purpose of this pending solicitation is to provide the resources and services needed to implement clinical research in support of NIAID’s mission. This will allow NIAID to respond to public health needs including public health emergencies and produce high quality data supporting regulatory and policy decisions. These services are intended to support: A wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II trials), fulfill regulatory requirements, and support Phase I/II clinical studies. NIAID priority activities including manufacture and characterization of reagents and products to support government supported clinical trials such as those supported by IDCRC. Manufacture of critical reagents and clinical trial material to support the wider scientific community and non-government sponsored projects. NIAID has implemented a Determination of Exceptional Circumstances in accordance with 37 C.F.R. § 401.3(e) (see Advanced Understandings) for NIAID’s preclinical service contracts that include Vaccine (and Other Biologic) Manufacturing Services for Infectious Diseases. Consequently, all contractors are required to operate under a fee-for-service model, and the contractor may be required to assign any intellectual property they file on third part material of information (“Provider Materials”), or new processes, and products relating to Provider Materials they develop and manufacture. The contractor will also be required to delay any public release of results until NIAID and Provider have a chance to review and file patents of their own. The contractors may propose the use of reagents and processes that are proprietary or under license. However, NIAID and the Provider reserve the right to reject the use of these alternative materials and processes.