SOURCES SOUGHT
A -- Data Management and Data Warehousing
- Notice Date
- 8/14/2018
- Notice Type
- Sources Sought
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 5601 Fishers Lane, 3rd Floor MSC 9822, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- SSBSNIHAO201800011
- Archive Date
- 9/13/2018
- Point of Contact
- Kathleen Marie Stotish, Phone: 3017617467, Callie Prassinos, Phone: 240-669-5155
- E-Mail Address
-
kate.stotish@nih.gov, Callie.prassinos@nih.gov
(kate.stotish@nih.gov, Callie.prassinos@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Data Management and Data Warehousing NIHAO201800011 Type of Requirement 1 Follow-on (Contract No.:_HHSN27220150001C_) Place of Performance 1 Place of performance is unknown at this time Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821 Sources Sought Notice Information 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 and Introduction: The National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC) was established to facilitate basic and clinical research in vaccine development and testing and is housed in the National Institute of Allergy and Infectious Diseases (NIAID). Purpose and Objectives: Currently, the VRC has a need for a comprehensive data management plan and reliable Clinical Data Management System (CDMS) that will help the center achieve compliance and meet requirements for the proper conduct of protocols for subject screening, collection of research samples, clinical trials subject enrollment, and follow-up activities for evaluation of new investigational products. Project requirements: The Contractor shall provide and manage a validated Clinical Data Management System (CDMS) that will track, process, and provide reporting on clinical trial and research specimen data input by the NIAID VRC program. The Contractor shall create, manage, and maintain a secure repository for current and historical clinical trials outcomes and data mining and reporting. The Contractor shall further provide established facilities, infrastructure, equipment, qualified personnel, and all necessary resources and services for archiving, updating and maintaining surveillance, and other types of research data from the VRC research activities. Anticipated period of performance: It is anticipated that one (1) Level of Effort/ Cost-Reimbursement Contract will be awarded. The period of performance will be for seven (7) years. Capability statement / information sought: Source must have the expertise, personnel, and facilities to meet the requirements of the project stated herein. Tailored capability statements submitted as a result of this notice must demonstrate the organization's qualifications and experience, specifically providing evidence as to the organization's capability to perform the requirements stated herein, with particular attention to the following: 1) Establish and manage of a state-of-the-art tested and proven commercial or proprietary CDMS software for the Electronic Data Capture (EDC) of clinical trials data. The Contractor provided system shall meet the standards set by the CFRs and recommended in FDA guidance, and shall be compatible with existing VRC-utilized CDMS systems (SAS data or SAS-convertible of transferable data.) All data must be accessible in real time, secure, and auditable at all times. Additionally, all clinical data must be formatted so the reports and analyses can be quickly generated for submission to the VRC, FDA and designated collaborated as needed. 2) The proposed CDMS must be usable within six weeks of award. 3) The Contractor will provide statistical support services related to data contained in the CDMS, including SAS datasets. 4) Warehousing data will mainly be generated from the CDMS. 5) This requirement shall provide the NIAID with the ability to perform frequent review of interim safety and accrual data during the conduct of clinical trials, ensure that clinical and laboratory results related to clinical trials of novel vaccine constructs can be rapidly and efficiently analyzed upon study completion, and provide more effective opportunities for necessary compilation and comparison of data across studies. 6) The Government will not be providing a system or provide support to build this system. Offerors must establish and provide access to CDMS. 7) The availability, adequacy and suitability of an established center facility, equipment and other resources including computer equipment, network infrastructure, database management systems, and overall information technology systems administration of the organization and all proposed subcontractors for data collection, computer processing, storage, tracking and retrieval of all study data and study-related information. 8) The ability to provide adequate scientific and technical personnel who have knowledge of protocols for subject screening, collection of research samples, clinical trials subject enrollment, and follow-up activities for evaluation of new investigational products. Must also have demonstrated ability to identify and resolve problems encountered in meeting milestones and timelines for projects of similar scope, size, and complexity. 9) The ability to provide a technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities. Capability statements must specify the offeror's business size and type, and demonstrate similar work that has been performed in the past and the dollar value of that work. Capability statements should also clearly demonstrate the offeror's ability to fully meet the technical and personnel requirements specified above and in the attached SOW. Note that this is not a request for proposals. This notice is for small business respondents only. As such, capability statements should also include documentation indicating that offeror's business size meets current standards as determined by the Small Business Administration's Table of Size Standards located at: (https://www.sba.gov/content/small-business-size-standards) for NAICS 541511. This SBA size standard is currently 750 employees, but is subject to change. Prospective offeror's may also note whether they meet any other socio-economic business categories such as 8(a), Hub-Zone, or Service Disabled Veteran when submitting their capability statement. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes, describing the organization's experience and ability to perform the efforts stated herein, which includes the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) the capability to provide the required level-of-effort on a continuing and emerging needs basis; (4) resumes for proposed key personnel, which reflect education, and previous work relevant to the proposed requirement; and (5) a general description of the facilities and other resources needed to perform the work. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. 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 six 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. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All information received within fifteen (15) days after the date of publication of this synopsis will be considered by the Government. Number of Copies: Please submit one (1) electric copy of your capability statement in response to the SMALL BUSINESS SOURCES SOUGHT notice to Kate Stotish, Contract Specialist, at Kate.Stotish@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00PM (Eastern Prevailing Time) on August 29, 2018. 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 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).
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