Florence RDCRN NOI.pdf

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Notice of Intent for NIH/NCATS Florence eTMF and Sitelink Subscriptions Renewal
Solicitation number
PCA-NCATS-06730
Issued by

About this file

This is a Notice of Intent to Award a Sole Source Contract issued by the National Institute of Health's National Center for Advancing Translational Sciences (NCATS) Rare Diseases Clinical Research Network (RDCRN). The Government intends to award a firm fixed price sole source contract to Florence Healthcare, Inc. (600 Peachtree Street NE, Suite 920, Atlanta, GA 30308) under FAR 12.102(a) authority, with only one source being available to meet the Government's needs. The contract covers renewal of the Florence electronic Trial Master File (eTMF) platform and associated SiteLink/eBinders services as a Software as a Service (SaaS) subscription for one 12-month base period. The NAICS code is 541511.

The required SaaS services include annual subscription services, SiteLink/eBinders access, Single Sign-On (SSO) integration support, technical support and maintenance, training services, site activation and onboarding support, and compliance and validation support documentation. The Florence platform provides centralized regulatory document management and clinical research documentation management across multiple RDCRN studies and participating research sites and is essential to RDCRN operational continuity. This notice is not a request for competitive proposals or quotes; no solicitation document exists. The Government will not be responsible for costs incurred in responding to this notice, and the determination not to compete remains solely within the Government's discretion. Questions should be directed via email only to Leah L. Hinson (Leah.Hinson@hhs.gov) with the subject line "Notice of Intent Question Submission – PCA-NCATS-06730 Florence eTMF RDCRN Subscription Renewal."

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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.

Questions or comments to this Notice of Intent should be directed to the Primary Point of Contact Leah L. Hinson via e-mail only Leah.Hinson@hhs.gov (no phone calls/voice mail). Messages regarding questions will not be accepted and will not receive a response). Please indicate in the subject of your email: Notice of Intent Question Submission – PCA-NCATS-06730 Florence eTMF RDCRN Subscription Renewal.

Contracting Office Address:

Office of Mission Acquisition Solutions (OMAS) Office of Acquisitions (OA) | Assistant Secretary for Financial Resources (ASFR) U.S. Department of Health and Human Services

Primary Point of Contact:

Leah L. Hinson- Leah.Hinson@hhs.gov

CLOSING STATEMENT
Contracting Office Address:
Primary Point of Contact:

File details come from the government source that posted it. Updated .