SOURCES SOUGHT
A -- Translational Research Informatics and Operations Support
- Notice Date
- 3/24/2016
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NCATS-SBSS-16-004
- Archive Date
- 4/29/2016
- Point of Contact
- Amanda M. Gramlich, Phone: 3014438761, Jeffrey R. Schmidt, Phone: (301) 402-1488
- E-Mail Address
-
amanda.gramlich@nih.gov, schmidtjr@mail.nih.gov
(amanda.gramlich@nih.gov, schmidtjr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 determine the availability and capability of small businesses (see FAR 19.000(a)(3)) to provide resources to support clinical operations and management of NCATS clinical research programs including the CTSA program. 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 & Purpose As part of its overall research mission, NCATS has an extensive clinical research portfolio that covers a broad range of clinical efforts. Currently most of the clinical and data coordination efforts are accomplished through a decentralized approach, with unique arrangements being made for each study. Coordination across these various entities, as well as centralized operations support and oversight, does not currently exist. This new contract requirement will provide centralized administrative and clinical operational support to NCATS-supported studies. The contractor will provide resources to ensure sound and efficient clinical study coordination and tracking for NCATS. This contract will provide clinical, operational, administrative and informatics support for the CTSA Program to achieve its goals to catalyze clinical and translational science. The CTSA Program supports a national network of medical research institutions that work together to improve the translational research process to get more treatments to more patients more quickly. The CTSA Program research centers serve as hubs to catalyze innovation in training, research tools, and processes. The contractor will assist NCATS staff in managing the clinical and operational activities and provide information management of NCATS' clinical activities and programs. A centralized information system will allow NCATS to quantify and describe characteristics of clinical studies to analyze the overall clinical program and serve as an information clearinghouse for the CTSA Program and network. Additionally, the awardee will provide support for ensuring human subject safety and quality monitoring of NCATS clinical studies. Project Requirements Written capability statements should demonstrate your organization's ability and related experience in the following areas: I. Clinical Operations Support a. Protocol and study-related document development including technical writing. b. Providing Safety monitoring and oversight. c. Data collection, management and quality control. d. Quality management and clinical site monitoring. e. Regulatory support for clinical trials. f. Good clinical practice (GCP) education and study-related educational activities. g. Development of templates and tools for improving operation of translational research. h. Study specimen storage and shipping. II. Clinical Operations Information Management a. Developing/providing, maintaining, and operating a secure centralized system in support of clinical operations. b. Developing/providing, maintaining, and operating a website in support of clinical operations. c. Designing and developing IT systems using JavaScript Object Notation (JSON) based REpresentational State Transfer (REST) Application Programming Interfaces (API). d. Designing, developing, and deploying an Electronic Data Interchange (EDI) mechanism to receive, store, and exchange data among different organizations. e. Providing access to materials through a secure web based system. f. Providing web-based information and reporting of activities and tasks. g. Providing data reporting and interactive data visualization to allow users to visualize and understand complex combinations of data from various sources. III. Overall Project Management a. Providing and maintaining an infrastructure for overall project management. b. Providing overall coordination and collaboration among various stakeholders to ensure communication and information sharing. Anticipated Period of Performance The Government anticipates awarding a Cost-Reimbursement, Level-of-Effort type contract under the future solicitation. The planned contract will consist of one (1) base year with four (4) option years for a total of five (5) years. The Government anticipates awards will be made during FY2017. Other Important Considerations Information management systems and reporting tools will be expected to be operational within 60 days. Offerors will be expected to have existing systems that can adapted for use for this contract. Required Information All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code. Submission Instructions and Due Date Written capability statements must be SUBMITTED NO LATER THAN APRIL 14, 2016 to the below Contracting Office Address, Attn: Amanda Gramlich. Electronic capability statements will be accepted by the primary point of contact. 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). Contracting Office Address National Center for Advancing Translational Sciences NINDS R&D Contracts Management Branch 6001 Executive Boulevard Suite 3287, MSC 9531 Bethesda, Maryland 20892-9531* *Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NCATS-SBSS-16-004/listing.html)
- Record
- SN04062107-W 20160326/160324235300-f6dd4822b88f084d7131d09f7a642338 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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