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SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95025R00012 Title: Clinical Research Operations & Management System (CROMS) 2.0 Classification Code: R499 NAICS Code: 541512 Size Standard: $34 mi... SAM.gov SOURCES SOUGHT NOTICE Solicitation Number: 75N95025R00012 Title: Clinical Research Operations & Management System (CROMS) 2.0 Classification Code: R499 NAICS Code: 541512 Size Standard: $34 million Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of 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; or small disadvantaged businesses; and (3) their size classification relative 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 strategy, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies 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. Recent Industry Day: An industry day was held on October 28, 2024, 2-3 pm Eastern. Please refer to the attached pdf of the slides and answers to questions posed. The industry day was recorded and can be accessed here: https://youtu.be/-wVxQP26oIM Background: The National Institute on Aging (NIA), one of the 27 Institutes and Centers (ICs) of the National Institutes of Health (NIH), leads the federal government in conducting and supporting research on aging and the health and well-being of older people. The successful deployment of the NIA Clinical Research Operations & Management System (CROMS) v1.0 by the NIA marked a significant stride in addressing the urgent need for a sophisticated institute-wide informatics system. The NIA CROMS is an NIA-wide system application is comprised of multiple components and supports the clinical research information needs of the NIA by providing comprehensive administrative and scientific information management for each NIA supported clinical study. This complex and expansive system plays a critical role in the real-time collection, tracking, reporting, and management of the Institute’s diverse clinical research data and portfolio. Support for the CROMS system is overseen by the NIA Office of Clinical Research (OCR) and is provided by Digital Infuzion, Inc via task order HHSN316201200128W/75N95020F00001. Purpose and Objectives: NIA’s objective is to continue to design, develop, maintain, and operate a unified and integrated Clinical Research Operations & Management System (CROMS) that supports the unique data and clinical research process needs of NIA’s ERP and provides an institute-wide informatics capability to track, report and manage NIA’s clinical research data, activities, and portfolio in real time. Project requirements: Specific objectives include, but are not limited to: Maintain and enhance, as requested, a state-of-the-art, high value software solution in a timely manner. Evaluate, plan, and adapt new components/capabilities in response to changing business strategies, policy, and regulatory changes. Enable OCR to obtain high quality technical expertise at a reasonable cost. Respond to wide range of in-scope business needs. Provide continual process and service delivery improvements. Support the system development lifecycle including investigating software requests, gathering and analyzing requirements, designing solutions, developing and coding software, configuring commercial off-the-shelf (COTS) components, documenting system changes, platform and application deployment, and disposition of system as appropriate. Additional details on the requirements can be found in the attached draft Statement of Work. Anticipated period of performance: Base Year: July 1, 2025 – June 30, 2026 Option Year 1: July 1, 2026 – June 30, 2027 Option Year 2: July 1, 2027 – June 30, 2028 Option Year 3: July 1, 2028 – June 30, 2029 Option Year 4: July 1, 2029 – June 30, 2030 Capability statement /information sought: Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address the items listed below. Additionally, the capability statement should include 1) the professional qualifications of personnel as it relates to the requirements outlined, 2) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 3) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. NIA is requesting that interested companies provide responses to the following: Please describe your company’s capabilities and prior experience in the following areas: Custom software development and implementation of a clinical research management system tailored to directly support the full range of processes required across the lifecycle of a clinical study and the related clinical research organization’s business processes. Indicate if experience is within NIH or a similar government agency that manages a portfolio similar to that of the NIA; as well, describe if your said experience for the clinical research software is across multiple organizations. If you have performed similar work in a commercial setting, describe your experience and how it would related to NIA. Subject matter expertise and experience supporting organizations in conducting clinical trials and managing related operational processes supporting large network of grantees (1000+) for NIH ICs that do not hold INDs but have clinical, regulatory, and administrative oversight. Subject matter expertise and experience supporting the management of over 300 Data and Safety Monitoring Board (DSMBs) in creating review agendas, managing conflict of interest (COI) for over 1000+ DSMB members and 600+ Independent Safety Monitors (ISM)/Safety Officers (SO), management of blinded and unblinded review documents, and distribution of review materials and recommendations. Expertise in and process for following Good Practices (GxP) guidelines, meeting regulatory compliance (e.g., 21 CFR Part 11), Human Subjects Protection (HSP), and ensuring systems are fit-for-purpose. Company’s project management approach that ensures compliance with various internal and external mandates, functional and non-functional requirements, and user satisfaction throughout the software development lifecycle. Describe your experience in successfully taking over and adopting another vendor’s existing software platform system, adapting it to meet a client’s needs, and ensuring a smooth transition with minimal disruption and measurable outcomes. Describe a technology stack your company has used for custom systems development. Include the tools used for application lifecycle management. Describe your company’s experience and processes to manage a Cloud-based (e.g., Amazon Web Services, Google Cloud Platform, Microsoft Azure) environment that supports a custom developed clinical research management system and associated infrastructure at NIH or a similar government agency. If you have performed similar work in a commercial setting, describe your experience and how it would related to NIA. Please state your agreement with the following statement. You must comply with the Limitation on Subcontracting. Please detail any joint ventures, teaming arrangements, or strategic alliances, including the names and capabilities of any potential partners. Please describe how you would manage subcontractors to ensure accountability and success in fulfilling the draft SOW requirements and hold them accountable to the successful completion of the work outlined in the draft SOW. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with 1.5 spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to fifteen (15) page limit. The 15-page limit does not include the cover page, executive summary, or references, if requested. All questions and responses must be submitted to Karen Mahon, Contracting Officer, at e-mail address Karen.Mahon@nih.gov and Kevin Alvarez, Contract Specialist, at Kevin.Alvarez@nih.gov. Any questions regarding this sources sought notice must be received by November 18, 2024, 1:00 pm Eastern Time. All questions and responses will be posted on this notice. The response must be received on or before December 6, 2024, 9:00 am, Eastern Time. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).