75N95022R00014 NINDS Center for Clinical Trial Resources - Pre Sol Notice - Final.pdf

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION

ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS WILL BE ISSUED VIA

SAM.GOV ON OR ABOUT 15 DAYS FROM THE DATE OF THIS ANNOUNCMENT

(ON OR ABOUT APRIL 26, 2022).

FULL TITLE: " NINDS Center for Clinical Trial Resources "

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 a contractor to provide scientific resources and services for the NINDS Center for Clinical Research Resources (hereinafter “Center”). 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 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.

The requirement objectives are: 1) 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; 2) 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; 3) 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; AND 4) 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.

Independently, and not as an agent of the Government, the Contractor shall furnish the necessary services, qualified personnel, material, equipment, and facilities required to serve as a Center for Clinical Research Resources that accomplishes the work described below. The Contractor shall provide scientific resources and services necessary for a broad range of activities required to support the NINDS clinical research program effectively. This includes multiple activities requiring advanced expertise in the design, conduct, and oversight of clinical research. Although four distinct performance areas have been identified and defined, it is impossible to anticipate every need of the NINDS DCR because the future clinical research and their associated unique demands are unknown, and because of possible unanticipated NINDS and NIH policy changes.

The Contractor shall provide clinical research professionals with broad enough expertise to handle such unanticipated needs. Examples of such possible needs include: preparation of the scientific background information needed to develop new scientific initiatives involving clinical research; and dissemination and translation of results from clinical research to the clinical community (patient and physician education).

The Contractor must be able to provide services to support a variety of scientific and technical services for the conduct of NINDS-sponsored clinical research. The Contractor shall provide services in four performance areas comprising the scope of work:

1. PERFORMANCE AREA #1: QUALITY ASSURANCE/QUALITY CONTROL

MONITORING SUPPORT

2. PERFORMANCE AREA #2: STATISTICAL AND METHODOLOGICAL

SUPPORT

3. PERFORMANCE AREA #3: CLINICAL DATA ACQUISITION AND ARCHIVING

SUPPORT

4. PERFORMANCE AREA #4: COMMON DATA ELEMENTS SUPPORT

The contract type for this requirement is cost-reimbursement, term form (level-of-effort) whereby the Government derives immediate benefit throughout the course of performance.

It is anticipated that one award will be made for a base 1-year, plus four (4) successive 12-month Term Option periods, for a total potential performance period of 5 years. The contract will include a basic requirement, option quantities (for increased level of effort), and term options.

Subject solicitation will be issued on the basis of full and open competition whereby all responsible sources may submit a proposal which shall be considered by the agency.

The RFP will be made available electronically, on or about 15 days from the date of this announcement (on or about April 26, 2022) via the SAM.GOV website https://www.sam.gov. Offerors are responsible for routinely checking the SAM.GOV website for any possible solicitation amendments that may be issued.