Multiple Study Data Coordinating Centers for DIPHR

Purpose of this Announcement: 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; service-disabled; veteran-owned small businesses; HUBZone small businesses; 8(a) 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 and Project Requirements: The Division of Intramural Population Health Research (hereafter, DIPHR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to establish approximately two Data Coordinating Centers (DCCs) with management capabilities to support the original research projects conducted by its intramural investigators. DIPHR encompasses three branches: 1) Epidemiology Branch 2) Health Behavior Branch, and 3) Biostatistics & Bioinformatics Branch [https://www.nichd.nih.gov/about/org/diphr/about]. Potential sources must demonstrate and document evidence of superior data management and data quality monitoring practices for large (at least 250 participants), population-based studies (e.g., longitudinal, observational and randomized controlled trials). Sources must document evidence of sufficient resources to support at least 8 concurrent studies. Sources must demonstrate and document experience managing and monitoring data quality collected through open-source platforms (e.g., Redcap), or in developing and maintaining state-of-the-art, web-based data coordination and management systems that have the following characteristics: (a) ability to accommodate different types of data (e.g., electronic medical record data, DXA scans, radiographs, and ultrasound images, data from wearable devices); (b) access to all aspects of the data for each study with real-time data entry and monitoring capability (for all web-based systems, open source systems are preferred); (c) flexible data collection capability, including the ability to upload files from multiple sites or sources (e.g., laboratories, clinical facilities, study participants' homes); (d) ability to accommodate multiple remote users (e.g., study participants entering data from homes), including accommodating varying browsers and systems; (e) capability to process, handle and track biospecimens and/or other types of data (e.g. images) that may be collected in clinical sites or in study participants' homes. Potential sources should demonstrate experience providing transportable versions of proprietary systems for direct import into an open source platform. In addition, potential sources should demonstrate evidence of the ability to: (1) design and maintain a complete and intuitive website for use by research participants and staff; (2) develop apps to enable electronic data collection via multiple mobile systems; (3) develop data management plans and implement established metadata standards to provide accurate and comprehensive data documentation; (4) provide expert biostatistical, information technological, clinical or laboratory services as requested by the Government to meet the study's needs; and (5) provide other essential logistical support, such as scheduling conference calls, Steering Committee meetings or Data Safety and Monitoring Board (DSMB) meetings, along with the preparation of minutes for all such activities; (6) implement time- and cost-savings practices to avoid duplication of effort across different studies. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the criteria listed below. Interested Small Business organizations must submit Capability Statements in response to this notice demonstrating with evidence their qualifications, experience and expertise in the following technical areas: (1) Ability to develop and maintain a web-based data management system capable of accommodating several large and small studies simultaneously; (2) Extent to which the web-based management system meets the Government expectation of construction, running and being maintained on open-source or portable platforms; (3) Ability to support and coordinate the research activities of clinical sites; (4) Ability to identify and provide expert technological, biostatistical, information technological, clinical or laboratory services as requested to meet Government needs; (5) Demonstrated qualifications and experience of the proposed key research staff and proposed staffing plan for the conduct of the project; (6) Demonstrated capability to anticipate and resolve unforeseen difficulties in recruitment and retention of study participants, randomization, data entry, data management, and data transfer; (7) Demonstrated successful past performance consistent with both prospective cohort designs with longitudinal capture of time-varying data and biospecimens and randomized clinical and intervention trials; (8) Resumes of proposed personnel shall be submitted. Project manager must hold an appropriate advanced academic degree in statistics, biostatistics, or close-related field, and have a minimum of 8 years experience in the conduct of large, population-based, longitudinal studies. Anticipated Period of Performance: The anticipated contract type will be Indefinite Delivery Indefinite Quantity (IDIQ) with an ordering period of approximately 7 years. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the 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 is 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 to 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). RESPONSES: Interested businesses that believe they possess the capabilities necessary to undertake this project should submit an electronic copy of their capability statement clearly stating in the subject line of the email that it is in response to NIH-NICHD-DIPHR-SBSS-2018-6. Please limit responses to 15 pages or less excluding resumes. Electronic capability statements should be received by the Contracting Officer by 4:00 PM Eastern time on February 1, 2018. Capability statements must identify the business status of the organization (i.e. educational institution, non-profit, large business, small business, 8 (a), or other corporate or non-corporate entity). No phone calls will be accepted. Respondents must submit their capability statement via electronic submission only. Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project officer; (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, and a statement regarding industrial security clearance. Any other specific and pertinent information as it pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted. Please send your capability statement to the attention of Theresa Koomson at koomsont@nih.gov and Alice Pagan at pagana@mail.nih.gov.