Presolicitation Notice - Clinical Research Data Mgt and Systems Support.pdf

PRESOLICITATION NOTICE

CLINICAL RESEARCH DATA MANAGEMENT & SYSTEMS SUPPORT

Solicitation# 75N93022R00012

Note: This synopsis follows a Sources Sought notice that was released on March 10, 2022, under

HHS-NIH-NIAID-SS-AMOB-20012.

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL

BE ISSUED ON A LATER DATE.

Type of Requirement

New Requirement Re-competition (Contract/Task Order No.: _HHSN272201800005C) Expansion of (Contract/Task Order/RFP No.: ______________)

Place of Performance

Place of performance is unknown at this time Place of performance is known. Address or general location: Bethesda, Rockville & Frederick, MD

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Duration of contract: ___5___ Years (December 1, 2022 through November 30, 2027)

Anticipated award date: _November 30, 2022__

Presolicitation Notice Information

Introduction

The Division of Clinical Research (DCR) provides operational and technical support for clinical research data management for research studies within the Clinical Center at the National Institutes of Health (NIH) and for international outbreak response initiatives as directed by Clinical Director.

The Clinical Center at the National Institutes of Health (NIH) is the world’s largest hospital entirely devoted entirely to clinical research. It is a national resource that makes it possible to rapidly translate scientific observations and laboratory discoveries into new approaches for diagnosing, treating, and preventing disease. As part of the overall mission, the NIH Clinical Center provides the National Institute of Allergy and Infectious Diseases (NIAID) with clinical facilities and technology infrastructure required to support intramural clinical research. NIAID has developed the Clinical Research Information Management Systems of NIAID (CRIMSON) hosted on the Clinical Center infrastructure as a study specific documentation and workflow management tool to address many of the unique requirements of the NIAID Clinics. CRIMSON is a well-established mature clinical and scientific information system that has undergone generations of enhancements, improvements, and refinements in the past two decades. It provides mission-essential patient management, case report management, study management, adverse event reporting, study analysis and many other related activities. The formatted CRIMSON Progress Note is also an integrated element of the Clinical Center Hospital Medical Record.

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 COVID- 19 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 sam.gov. 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 https://ecps.niaid.nih.gov and then click on "How to Submit."

https://ecps.niaid.nih.gov/