Inactive

This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regardi... This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R&D requirement. This notice is issued to help determine the availability of qualified sources technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: To address the present and anticipated future needs of the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), the NINDS Division of Clinical Research (DCR) requires support services to establish and manage a Center for Clinical Research Resources. The overall purpose of the Center is to provide scientific and technical support toward the conduct of clinical research sponsored by the NINDS. The NINDS DCR is charged with ensuring the highest quality of each NINDS-funded clinical research project and compliance with Department of Health and Human Services (DHHS)/NIH/NINDS regulations and policies regarding human subject protection and safety monitoring. To ensure the highest quality product and most efficient use of resources, the NINDS DCR has a programmatic need for clinical research-related scientific and technical support. In FY 2020, based on the NIH Research, Condition, and Disease Categorization (RCDC) system, NINDS invested over $750 million in 1,255 clinical research projects and ranked ninth among NIH Institutes and Centers in spending on clinical research. Purpose/Objective: To provide the NINDS with scientific and technical support toward the conduct of NINDS-sponsored clinical research. Provide scientific/technical support in quality assurance and quality control in the conduct of NINDS-sponsored clinical research to ensure that the data resulting from a clinical research project are of the highest quality and are considered valid and credible within the scientific and clinical community, as well as the general public. Provide statistical and methodological support and analysis to the NINDS as related to the development of guidelines for prospective grant applicants and reviewers, the resolution of methodological problems in ongoing clinical activities, and overall statistical analysis of the NINDS clinical research portfolio to aid NINDS strategic planning. Provide scientific/technical support, guidance and services in clinical data acquisition, archiving, and distribution activities, in accordance with current NIH data management and sharing policy, in order to store and share / provide secure access to NINDS-sponsored clinical research data with the scientific research community. Provide scientific/ technical support and training for the ongoing development of a core set, and several disease-specific sets, of Common Data Elements (CDEs) for use in NINDS-sponsored clinical research. Project Requirements: The Contractor shall provide project management support for the overall administration of the contract and development, tracking, and management of all tasks under the contract. The Contractor’s support staff shall work in coordination with designated federal staff and be responsible for performing all the non-inherently governmental activities associated with administration of this contract. The NINDS has identified four specific performance areas comprising the scope of work under the contract.