Bespoke Gene Therapy Consortium Coordination Center (BGTC CC) Electronic Data Capture (EDC) Platform Support

SOURCES SOUGHT NOTICE Solicitation Number: 24-005328 Title: Bespoke Gene Therapy Consortium Coordination Center (BGTC CC) Electronic Data Capture (EDC) Platform Support Classification Code: DA10- IT AND TELECOM - BUSINESS APPLICATION/APPLICATION DEVELOPMENT SOFTWARE AS A SERVICE NAICS Code: 541519 - Other Computer Related Services Size Standard: $34 million Description: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: The Contractor shall: Provide Metadata Rave, a specialized EDC/eCOA SaaS, to support the centralized data management and analysis requirements of the BGTC along with multiple instances of Rave to support individual studies. Provide professional services, in coordination with the National Center for Advancing Translational Sciences (NCATS) Information Technology Resource Branch (ITRB), to initiate and configure the SaaS in compliance with NCATS data environment standards, including security, standardization, and sustainment. For information technology (IT) related areas, the NCATS ITRB is responsible for the operating system(s), databases, applications, system architecture, server, and security infrastructure provided and/or hosted by NCATS, while the contractor will be expected to be knowledgeable about and support these tasks and/or responsibilities in collaboration with ITRB as specified in the SOW. It is important to note that any system deployed is determined to be a government system, independent of the commercial nature of the service hosting the system, with the government as the official responsible party. The Contractor shall be responsible for post-activation, on-going system support and maintenance requirements for data-driven maintenance that is necessary from user activity across multiple sites and studies. Example maintenance items include, but are not limited to, database management, data reconciliation, data cleaning, and application of the Study Data Tabulation Model (SDTM). Background: The BGTC is part of the Accelerating Medicines Partnership (AMP) program, a public'private partnership among NIH institutes and centers (IC), the U.S. Food and Drug Administration (FDA), multiple pharmaceutical and life sciences companies, and nonprofit and other organizations. The AMP program, which is managed by the Foundation for the NIH (FNIH), aims to improve current models for developing diagnostics and therapies. NCATS is the lead NIH IC for BGTC, one of several NCATS-led programs aligned with the NCATS mission to re-engineer the translational research process so new treatments and cures for diseases can be delivered to patients faster. The BGTC is establishing platforms and standards to speed the development and delivery of customized or - bespoke gene therapies (GT) that could treat millions of people affected by rare diseases, including diseases too rare to be of commercial interest. BGTC program management is performed through the BGTC Coordination Center (BGTC CC). The BGTC CC coordinates consortium development of early-stage gene therapy drug candidates (currently 7 candidates) to treat selected rare diseases. Gene therapy development includes early-stage drug development, pre-clinical evaluation, regulatory preparation, and program platform operations in advance of initiating clinical trials. To meet the data management requirements for this gene therapy effort, the BGTC CC is developing a centralized regulatory and Quality Management System (QMS)-compliant Electronic Data Capture (EDC) and electronic Clinical Outcome Assessment (eCOA) platform that will be used by all participants in this drug development effort. The BGTC has standardized on Metadata Rave, a commercial, widely used cloud-based EDC software as a service (SaaS), as the platform for secure clinical trial data services. To meet the requirements for privacy, security, and long-term sustainability of all data collected in support of the BGTC, the Government will contract for the cloud platform services that support BGTC data collection, dissemination, analysis, integration, reporting, and management. Purpose and Objectives: To obtain cloud-based electronic data capture (EDC) software and provide services to provision it in accordance with NCATS data environment standards to support clinical data management and analysis requirements of the Bespoke Gene Therapy Consortium (BGTC). Project requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the below: The Contractor shall: Provide Metadata Rave, a specialized EDC/eCOA SaaS, to support the centralized data management and analysis requirements of the BGTC along with multiple instances of Rave to support individual studies. Provide professional services, in coordination with NCATS Information Technology Resource Branch (ITRB), to initiate and configure the SaaS in compliance with NCATS data environment standards, including security, standardization, and sustainment. For information technology (IT) related areas, the NCATS ITRB is responsible for the operating system(s), databases, applications, system architecture, server, and security infrastructure provided and/or hosted by NCATS, while the contractor will be expected to be knowledgeable about and support these tasks and/or responsibilities in collaboration with ITRB as specified in the SOW. It is important to note that any system deployed is determined to be a government system, independent of the commercial nature of the service hosting the system, with the government as the official responsible party. The Contractor shall be responsible for post-activation, on-going system support and maintenance requirements for data-driven maintenance that is necessary from user activity across multiple sites and studies. Example maintenance items include, but are not limited to, database management, data reconciliation, data cleaning, and application of the Study Data Tabulation Model (SDTM). Government Responsibilities The Government intends to ultimately be responsible for security and sustainment of the EDC/eCOA platform, as the studies may require data management for 8 years or longer. The Government shall provide direct technical guidance and coordination to the Contractor related to NCATS data environment standards, including security, standardization, and sustainment. The NCATS Information Technology Resources Branch (ITRB) is responsible for the operating system(s), databases, applications, system architecture, server, and security infrastructure provided and/or hosted by NCATS. It is important to note that any system deployed is determined to be a government system, independent of the commercial nature of the service hosting the system, with the government as the official responsible party. Rights in Data Medidata is a commercial SaaS subject to commercial terms and conditions. Data rights will be governed by FAR 52.227-14 Rights in Data - General. All custom software code shall be deposited in a Government controlled repository (currently GitHub) and is subject to unlimited rights in the Government. The EDC/eCOA platform shall be a Government system developed at Government expense. Limited rights data or restricted computer software shall not be incorporated without contracting officer authorization. Delivery or Deliverables The contractor shall deliver: A centralized EDC system to support all projects of the BGTC. Instances of Metadata Rave to support individual studies. Professional services to initiate and configure the implementation of Metadata Rave, in compliance with NCATS ITRB requirements. Anticipated period of performance: The base period of performance is one year, with option periods and options for additional services. Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. In case domestic sources are available and capable of fulfilling the Government's need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products or services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) 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 4) 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. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. 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 must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. 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. 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 single or double spacing. The information submitted must be in and 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 ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Maggie Brant at e-mail address maggie.brant@nih.gov. The response must be received on or before August 1, 2024, 4:00 pm, Eastern Time. - 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 presolicitation 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).