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

Closed Special Notice Posted

Solicitation number
PCA-NCATS-06730
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Bethesda, Maryland 20892, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institute of Health's National Center for Advancing Translational Sciences (NCATS) Rare Diseases Clinical Research Network (RDCRN) issued a notice of intent on July 28, 2026, to award a sole source firm fixed price contract to Florence Healthcare, Inc., for renewal of its Florence electronic Trial Master File (eTMF) platform and SiteLink/eBinders services; no competitive solicitation will be issued, and this constitutes a synopsis under FAR 12.102(a) authority based on only one source being available to meet the Government's needs. The 12-month SaaS subscription renewal supports centralized regulatory document management and clinical research documentation across multiple RDCRN studies and participating research sites, essential to RDCRN operational continuity. Included services cover annual subscription access, SiteLink/eBinders functionality, Single Sign-On (SSO) integration support, technical support and maintenance, training services, site activation and onboarding, and compliance and validation support documentation. The NAICS code is 541511. The Government will not bear response costs, and the determination not to compete remains solely within Government discretion. Questions should be directed via email to Leah L. Hinson at Leah.Hinson@hhs.gov with subject line "Notice of Intent Question Submission - PCA-NCATS-06730 Florence eTMF RDCRN Subscription Renewal."

Notice text

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.

Files

File Type Posted
Florence RDCRN NOI.pdf PDF

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