NIH Pre-solicitation: Clinical Research Data Management and Systems Support

Notice ID 75N93022R00012
Related Notice HHSNIH-NIAID-SS-AMOB-20012

Purpose & Objectives

The activities supported by this contract focus on the implementation, operations, and maintenance of systems and data processing workflows supporting NIAID clinical research studies. Although solutions will be required to remain agile and responsive to changing needs of the clinical research community, the goal is to continue to enhance and modernize the foundational core tools set. This foundational framework and tools will include the design and implementation of systems, user support and operations, as well as core infrastructure and technology support.

Objectives of the proposed contract include support, enhancement, and development of Clinical Research Information Management systems across the complete research data lifecycle (definition, collection, storage, analysis, and reporting) of studies as requested by the NIAID Division of Clinical Research (DCR). The dynamic nature of DCR’s mission requires current systems be capable of not only supporting research studies within the NIAID clinics as part of the NIH Clinical Center, but also able to be deployed as part of a response to emerging disease outbreak in remote and diverse international locations. The primary focus of the contract is for the maintaining and expanding (if necessary) of stable and proven systems and technical platforms (e.g., CRIMSON, STORM etc..) to create a core capability of systems and expertise to provide DCR with consistent clinical research data management functionality that leverages the reusability of operational data management systems across projects, deceasing complexity of initiating new studies.

The Division of Clinical Research (DCR) Data Management and System Support team leverages existing systems and expertise through the operations and technical capabilities provided through this contract. The mission of DCR has become increasing focused on supporting clinical research as part of an emergency response to disease outbreak. The evolution of the mission has resulted in the creation of the Clinical Trials Research Sections (CTRS) to develop and provide operational efficiencies and data integrity for special projects and rapid response initiatives. Primarily established in response to Ebola outbreak in West Africa and the COVID19 pandemic, CTRS has become DCR’s core resource for study design, implementation, and data management for emerging disease responses. As part of this emerging mission DCR has developed an automated approach for defining, collecting, processing, and managing the use of Case Report Form (CRF) as a data collection process. The Study Tracking & Online Reporting Management (STORM) is early in its use but shows promise as a cornerstone for DCR remote data management workflows. It is a primary goal of this contract to support the data lifecycle of these studies or special projects. The Government anticipates that ONE (1) stand-alone contract will be awarded as a Cost-Plus Fixed Fee (CPFF) type contract with a 5-year period of performance. The North American Industry Classification System (NAICS) code for this requirement is 541690 with a size standard of $16.5 million. Any responsible offeror may submit a proposal which shall be considered by the Agency. It is anticipated that the Request for Proposal (RFP) will be available electronically on about July 25, 2022 and may be accessed through The RFP will be advertised as a small business set-aside. WE ENCOURAGE ALL RESPONSIBLE SOURCES TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls shall be accepted. No facsimile transmissions shall be accepted. IT IS THE OFFEROR’S RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website and then click on “How to Submit.”

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