SOLICITATION NOTICE
D -- Transplant Survivorship REDCap Database and Coordination Center
- Notice Date
- 9/1/2016
- Notice Type
- Presolicitation
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-HL-2016-279-JML
- Archive Date
- 9/23/2016
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Vanderbilt University, 1161 21st Avenue, Suite D3300, Nashville, TN 37232-0011 to provide support services for the Transplant Survivorship REDCap Database and Coordination Center. BACKGROUND The National Institutes of Health (NIH) Blood and Marrow Transplant (BMT) Late Effects Initiative requires the development and purchase of a transplant survivorship databasing system. This will be used to develop a prospective registry of hematopoietic stem cell transplant survivors for intramural and extramural collaborative research. PURPOSE The database goals are to establish a multicenter, well-annotated cross-sectional (~1000 subjects, >5 years post-transplant) as well as longitudinal (500 subjects between 1 to 4 years post-transplant) survivorship cohort. These numbers are necessary to capture early as well as late events, identify rare events with long latency, and to account for attrition from competing risks. The success of this project will depend upon maintaining a well operationalized and annotated database on a web-enabled platform, with ability for source validation, query resolution, automated and on-demand reporting ability, and seamless interaction with established statistical software. In addition, this database should link either directly or through an intermediate platform with existing registries, to avoid duplication of data entry and add value to the following focus areas: health care economics and personal medicine. The database should also serve as a link to a repository for samples and eventually be able to "talk" with next generation sequencing platforms for high throughput genomic / proteomic association analyses. The goal would be to develop a platform using latest technologies in cloud computing, to allow this priceless data to be interrogated using current and emerging technologies for the next 10-15 years. The project will have two major cohorts: a cross sectional cohort of 1000 patients who are > 5 years' post-transplant and a longitudinal cohort of 500 patients who will be 1-4 years post SCT at the time of enrollment and will be followed for the duration of the project. The creation of this database will leverage consultants at major academic centers / universities who have an established track record in clinical research, establishing community based cohorts, and have an established track record in using cohorts for personalized medicine using smart phone app based technology. CONTRACTOR REQUIREMENTS The contractor shall serve as the data coordination center and will include consultants on a scientific panel consisting of following skill sets: - Database design; - Case report form generation; - Database report generation; - Development of a multicenter natural history protocol to capture transplant survivorship data; - Cohort construction and maintenance; - Health care economics; - Chronic disease; - Cloud computing / app development; - Clinical researcher in late effects, chronic GVHD and impact on late effect; and, - Expert in quantitative sciences / statistics. The main focus of the panel will be to provide intellectual input to construct the cohort, accept scientific proposals that will be generated to interrogate the cohort, to provide guidance on analyses to individual investigators, and help frame the best questions that add value to this undertaking. The work performed shall consist of the following two stages: Stage 1. This work includes all up-front costs of database development including: (1) all database programming in Synalytics, including building study events, study forms, variable and event-specific logic (branching logic and validations), user permissions, and user groups, and (2) development of all technical documentation as well as user documentation and training materials. Stage 2. This work includes implementation of comprehensive data query and reporting pipelines, for example, query interface, report-building interface, and development and implementation of user-requested tables, summary statistics, and other reporting metrics, generated in real-time through ‘one-click' access available via the user interface. PERIOD OF PERFORMANCE The period of performance is estimated to begin in September 2016. JUSTIFICATION The sole source determination is based on the following information: REDCap (Research Electronic Data Capture) is a mature, secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data, it is specifically geared to support data capture for research studies. REDCap can be installed in a variety of environments for compliance with such standards as HIPAA, 21 CFR Part 11, FISMA (low, moderate, high), and international standards. REDCap is the only databasing system available with the following critical features: -Availability - Software is available at no cost for REDCap Consortium Partners. -Secure and web-based - Input data or build an online survey or database from anywhere in the world over a secure web connection with authentication and data logging. -Fast and flexible - Conception to production-level database or survey in less than one day. -Multi-site access - REDCap databases / surveys can be used by researchers from multiple sites and institutions. -Autonomous utilization - Research groups have complete autonomy and control to add new users. -Export data to common data analysis packages - Exports raw data and syntax files for SAS, Stata, R, and SPSS. -Fully customizable - Total control of shaping your database or survey. -Advanced features - Mid-study modifications, auto-validation, branching logic, and calculated fields. Vanderbilt University has a very broad set of implementation skills that uniquely distinguish it from others in the field based on the following information: -As the originators and developers of Project REDCap, Vanderbilt University has unique knowledge and significant experience implementing this platform. -Vanderbilt University is also focused on developing and utilizing databasing models to address transplant survivorship and, therefore, has a concentration of experience and expertise that is not readily found anywhere else. -Vanderbilt University has significant International recognition, experience, and proven leadership in the field of transplant survivorship (Dr. Bipin Savani) and Chronic GVHD (Dr. Madan Jagasia). Vanderbilt University has advanced knowledge, program staff and experience programming REDCap databases for clinical trials. Synalytics is the Vanderbilt Center for Quantitative Sciences (CQS) open‐source software system for rapid development and implementation of electronic data capture (EDC) systems to meet a wide range of clinical and non‐clinical biomedical research needs. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), Soliciting from a single source (for purchases not exceeding the simplified acquisition threshold), and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION The North American Industry Classification System (NAICS) Code is 541511, Custom Computer Programming Services, and the Small Business Size Standard is $27.5M. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-89-1 (August 15, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 8, 2016 at 12:00PM EST and must reference synopsis number NHLBI-CSB-HL-2016-279-JML. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, Maryland 20892-7902, Attention: Jonathan M. Lear. Responses may be submitted electronically to john.lear@nih.gov. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HL-2016-279-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesa, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04252472-W 20160903/160902000109-934eed0b4596a5eda153475556cf1827 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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