Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases

Sources Sought Notice Information Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, medical devices and diagnostics, which are funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, device and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center clinical research and Phase 0 through 4 clinical trials evaluating bacterial, viral and parasitic vaccines, therapeutics, and other biologics, drugs, diagnostics, medical devices, and approaches as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, examples include: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines, medical devices and therapeutics for a wide variety of emerging and re-emerging infectious diseases (http://www.niaid.nih.gov/topics/emerging/Pages/list.aspx), which includes NIAID Category A-C Priority Pathogens to meet critical public health needs. Purpose and Objectives The U.S. Government has a requirement for the establishment and management of a Statistical and Data Coordinating Center (SDCC) to support DMID's extramural clinical research programs. Project Requirements The project requirements of the SDCC include: computerized systems for the collection, storage, management, reporting and quality control of study data; preparation of study- related materials; clinical study websites; statistical design and analysis expertise; data management user training; clinical site capability assessment for data management; electronic specimen tracking system; data storage facility; and project/site management. Anticipated Period of Performance The Government anticipates making one (1) contract award. It is anticipated that the duration of the contract will be a maximum of seven (7) years. Other important considerations: N/A Capability statement / information sought Respondents are expected to have the expertise, personnel, and facilities to meet the requirements stated herein. Tailored Capability Statements submitted as a result of this notice should demonstrate the prospective respondents qualifications and experience, specifically providing evidence as to their capability to perform the requirements herein, with particular attention to the following technical areas: - Ability to carry out statistical design and analysis functions for Phase 0-4 clinical trials evaluating therapeutics, vaccines and devices for a wide variety of infectious diseases. - Ability to collect, manage, store and ensure quality of clinical (to include computer-based registration and randomization) and laboratory data in compliance with regulatory requirements, including 21CFR11, international guidelines and current globally accepted standards. - Ability to design, manage and update clinical study-related materials. - Ability to design, manage, update and ensure secure access to a clinical study website. - Ability to coordinate and collaborate with clinical research support services to facilitate study implementation and assess study progress. - Ability to provide training and technical assistance to participating clinical study sites. - Ability to design and manage an electronic specimen tracking system. - Ability to provide study/trial-specific project management. - Ability to serve as a data repository for completed clinical studies. Technical Plan/Approach: Addresses the appropriateness and adequacy of the plans for conducting all the activities described above. Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. It is estimated that 60 Full-Time Equivalents (FTEs) will be required for each year of the proposed contract. For the purposes of this notice, a Full-Time Equivalent is one (1) person- whether contractor employee, subcontractor employee, or consultant-who works 2,080 hours per year. It is anticipated that the Government may exercise options for increased level of effort that may result from unanticipated increases in demand, with the services required under the Options to be of the same scope provided during the Base year. Should the Government elect to exercise any of the Options, the Options may be exercised within the Base period (and within each year of the proposed contract), up to a maximum of 60 FTEs using any combination of Options 7 or 8. Facilities/Resources/IT Security: Addressed the adequacy, appropriateness of the facilities and resources dedicated to the project and security against catastrophic loss of data or important software. Past Performance: Past performance is considered essential. In addition to demonstrating that an offeror has met the above qualifications, interested parties must identify at least three (3) other projects of similar size and complexity. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. The font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than 6 lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: - DUNS. - Company Name. - Company Address. - Company Point of Contact, Phone and Email address - Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. - Do you have a Government approved accounting system? If so, please identify the agency that approved the system. - Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: For this Small Business Sources Sought, the NIAID requires capability statements to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit." Common Cut-off Date: Capability statements are due no later than [3:00 PM (Eastern Prevailing Time) on 10/01/2019]. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre- solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses for a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).