SAM Sources Sought Notice.pdf

THIS IS A SMALL BUSINESS SOURCES SOUGHT NOTICE (SSN) ONLY.

THIS IS NOT A REQUEST FOR PROPOSAL, QUOTATION, OR INVITATION

TO BID NOTICE AND DOES NOT CONSTITUTE A COMMITMENT BY THE

GOVERNMENT.

THERE ARE NO SOLICITATION DOCUMENTS AT THIS TIME. PLEASE DO NOT REQUEST

A COPY OF A SOLICITATION.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; economically disadvantaged women-owned small business, or small disadvantaged businesses; and (3) their size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable task areas should not submit a response to this notice. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the U.S. Government and will not be returned.

This market research is being conducted to identify sources that have prime contractor experience with Clinical Research Protocol Data Support. The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH accomplishes that mission by conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of biomedical information. NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. As one institute or center (IC) at NIH, the National Institute of Child Health and Human Development (NICHD)’s mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all.

The Division of Intramural Research (DIR) is responsible for planning and conducting the Institute’s laboratory and clinical research programs. DIR seeks fundamental knowledge about the nature and behavior of living systems through basic, clinical, and population-based research and determines how to apply such knowledge to illuminate developmental origins of health and disease and help ensure that women and men have good reproductive health, that children are born healthy, and that people develop to live healthy and productive lives. The research program emphasizes the importance of fundamental investigations into the physics, chemistry, and biology of cells, their component parts, and the processes that govern and regulate their function. As part of their investigative focus, the scientific researchers of the DIR accord primary importance to the transmission of new information to future generations of scientists.

The NICHD intramural clinical research program currently includes a range of protocols with five main areas of focus:

Adult, pediatric, and reproductive endocrinology Human genetics Public health (domestic and international) Typical growth and development Women's health

The protocols conducted by NICHD principal investigators include natural history studies, teaching protocols, and therapeutic trials. NICHD clinical protocols have contributed to multiple manuscripts and meeting abstracts.

Twelve affinity groups, comprising approximately 68 units and sections, make up the NICHD DIR.

This includes 68 tenured and tenure-track investigators, supported by an administrative and staff complement of roughly 767 personnel. Other ICs vary in size and personnel of their intramural programs.

Multiple specialized clinical research systems work in concert to support intramural clinical research.

The Clinical Trials Database (CTDB) is a web-based application that supports protocol design and clinical data. CTDB functionalities include multi-site capabilities, a biospecimen management module, a quality assurance module, a centralized question library, and an electronic regulatory binder module. The Clinical Trial Survey System (CTSS) is a web-based application with multi-language capability, is accessible outside the NIH, and allows patients to respond to clinical questionnaires remotely. The Clinical Data Mart and Reporting Tool (IBM Cognos) is a centralized data mart for consolidating data from the CTDB, CTSS, the NIH Clinical Center's Clinical Research Information System (CRIS), the Biomedical Translational Research Information System (BTRIS), and IC-specific systems (NHLBI CMRCoop, NIDCD audiology, NIMH imaging, NIMH e-screen).

Taken together, these systems form the basis of reporting and management for most of NICHD’s intramural clinical protocol data as well as many protocols in other ICs at NIH.

Each protocol is conducted by a research team under the direction of a Principal Investigator. The protocols are performed primarily at the National Institutes of Health (NIH)’s Clinical Center in Bethesda, Maryland; however, certain protocols have all or some of their research subjects evaluated or treated at other sites throughout the country. The clinical research support required by this contract will include not only NICHD users but also those in other ICs. There are approximately 1,200 active users of these clinical research systems that will require support by this contract.

The objective of this market research is to receive information regarding acquiring professional services to provide program/project planning, program management services, CTDB clinical protocol implementation and training, user support, clinical data management, application testing, support, and website development for the NICHD Clinical Program as well as for clinical programs in other ICs at NIH.

Current challenges include:

Lack/inconsistent direct feedback from principal investigators and other research staff that could otherwise be used to monitor and improve support.

Significant implementation complexity is due to work that involves not only NIH principal investigators but also collaborators from non-government facilities, universities, pharma, and regulatory bodies.

Due to the fast-evolving landscape in clinical research support and modernization, it can be challenging to accommodate a rapid influx of studies and stay current.

DIR works in close collaboration with contractor support and looks to use this support not only to provide subject matter expertise and strategic leadership advice, but also to assist DIR in managing risk across its dynamic mission and its large array of networks and information systems. DIR will take responsibility for approving and ultimate ownership of all work products and deliverables completed by the Contractor.

The contractor shall perform tasks in the following areas:

1. Program Management Services

2. CTDB Protocols Implementation and Training

3. User Support

4. Clinical Data Management

5. Application Testing, Support, and Websites Development

6. Transition Services

Information Requested

Please submit the following information:

I. Company Name, Address, Unique Entity ID, CAGE Code, and Point of Contact information for the interested Company.

II. Company’s size classification and socio-economic status.

III. Corporate Capabilities - Experience similar in scope, size, and complexity to the requirements.

IV. Relevant experience listing up to three (3) customers (Government/non-Government) within the past 5 years, providing:

a. Contract Name

b. Contracting Agency or Department

c. Yearly contract value in USD dollars

d. Period of Performance

e. System Metrics

V. Description of work, how it relates to DIR requirements.

VI. Any other relevant information that is not listed above which the Government should consider in finalizing its market research.

Submission Requirements

Page limits (not including a cover letter or introduction page) – Up to four (4) 8 ½” x 11” pages for corporate capabilities and up to three (3) 8 ½” x 11” pages for the relevant experience.

1-inch margins (top, bottom and sides)

Times New Roman – 12 point font

Interested firms responding to this market survey must provide a capability statement demonstrating their experience, skills, and capability to fulfill the Governments requirements for the above in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b). The capability statement shall be in sufficient enough detail so that the Government can determine the experience and capability of your firm to provide the requirements above.

Only electronic copies of capability statements will be accepted. A determination by the Government to proceed with the acquisition as a set-aside is within the discretion of the Government. Please submit all capability statements to Courtney Warren via email submission by Friday, September 19, 2025, at 3:00 PM. NO TELEPHONE REQUESTS WILL BE ACCEPTED.

DISCLAIMER

The Sources Sought Notice (SSN) is issued solely for information and planning purposes and does not constitute a solicitation. Responses are not offers and cannot be accepted by the National Institutes of Health to form a binding contract. The NIH reserves the right to request additional information or clarifications from respondents.