Notice of Intent for NIH/NCATS Florence eTMF and Sitelink Subscriptions Renewal

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT, NOT A REQUEST FOR COMPETITIVE QUOTES. A REQUEST FOR QUOTE (RFQ) WILL NOT BE ISSUED AND QUOTES WILL NOT BE REQUESTED. The National Institute of Health’s National Center for Advancing Translational Sciences (NCATS) Rare Diseases Clinical Research Network (RDCRN) intends to award a firm fixed price sole source contract under the authority of FAR 12.102(a), only one source being available to meet the Government's needs, to:

Florence Healthcare, Inc. 600 Peachtree St. NE, Suite 920 Atlanta, GA 30308 The National Center for Advancing Translational Sciences (NCATS) RDCRN hereby submits a notice of intent to award a sole source firm fixed price purchase order for a renewal of the Florence electronic Trial Master File (eTMF) platform and associated SiteLink/eBinders services. This request is to renew this Software as a Service (SaaS) subscription.

The required software is used in centralized regulatory document management across multiple RDCRN studies and participating research sites. The Florence platform supports centralized management of clinical research documentation and is essential to RDCRN operational continuity. The North American Industry Classification System (NAICS) code for this requirement is 541511. The SaaS includes the following:

• Annual subscription services • SiteLink/eBinders access • Single Sign-On (SSO) integration support • Technical support and maintenance • Training services • Site activation and onboarding support • Compliance and validation support documentation The period of performance will be for one (1) 12-month base period. This notice of intent is not a request for competitive proposals, and no solicitation document exists for the requirement. This hereby constitutes a synopsis of the requirement.

CLOSING STATEMENT The determination not to compete this proposed contract action, is solely within the discretion of the Government. Information received will normally be considered for the purpose of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs incurred by responding to this notice. This is NOT a request for quotes or proposals.