SOLICITATION NOTICE
D -- Institutional Review Board (IRB) Management Software
- Notice Date
- 10/9/2014
- 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
- HHS-NIH-NHLBI-CSB-HI-2015-008-CDB
- Archive Date
- 10/31/2014
- Point of Contact
- Chris Bocus, Phone: 3014027888
- E-Mail Address
-
chris.bocus@nih.gov
(chris.bocus@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 (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a sole source noncompetitive basis to provide the Institutional Review Board (IRB) software, iRIS, to iMedRIS Data Corporation, 446 Missouri Court, Redlands, CA, 92373-8083. Background: The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI stimulates basic discoveries about the causes of disease, enables the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. It creates and supports a robust, collaborative research infrastructure in partnership with private and public organizations, including academic institutions, industry, and other government agencies. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI also collaborates with international organizations to help reduce the burden of heart, lung, and blood diseases worldwide. The National Institutes of Health (NIH) was recently awarded AAHRPP accreditation. In order to maintain its accreditation, NIH requires all of its clinical programs to comply with newly implemented standard operating procedures regarding clinical protocol management. These standards are currently enforced through NIH's Office of Human Subject Research Protection. The NHLBI requires new IRB management software. The current system is outdated and incapable of meeting the NHLBI's requirements without undergoing a costly overhaul. This software must be also compatible with the other NIH IRB management software to effectively achieve the institute's mission. Purpose and Objective: The NHLBI requires new IRB management software. The current system is outdated and incapable of meeting the NHLBI's requirements without undergoing a costly overhaul. This software must be also compatible with the other NIH IRB management software to effectively achieve the institute's mission. The NHLBI will be procuring iMedRIS Data Corporation's "Intergrated Research Information System (iRIS). Contractor Requirements: The contractor shall provide the following products/services to the NHLBI: 1. Unlimited user licenses to iRIS (IRB Assistant Enterprise Edition, IRB Assistant Enterprise Edition -Deputy Ethics Counselor, and Scientific Board modules) 2. Software support and helpdesk availability Monday through Friday from 8 AM to 5 PM EST (except for Government Holidays) during the course of the contract. 3. Standard system updates and enhancements Period of Performance: To be negotiated upon award. Justification: The determination by the Government to award a contract without providing for full and open competition is based upon the FAR 6.302-1, the equipment and services are only available from iMedRIS Data Corporation. This project will be modeled from the already established National Institute of Health IRB system established by the National Cancer Institute (NCI) and requires the collaboration of NHLBI with NCI IT staff. NCI IT staff is only trained to use iRIS. They do not have the expertise to implement NHLBI's IRB workflow processes using any other system. Additionally, iMedRIS has the only knowledge of the existing system; any other contractor tasked to perform these services would result in delays and duplication of costs. Furthermore, the NHLBI does not have the funds available to contract out the customization of iRIS and/or any other IRB management system. The iRIS system is proprietary to MedRIS Data Corporation. Regulatory Authority: This acquisition is conducted under the authority of FAR Part 6.302-1(a) 2.ii., Only one responsible source and no other supplies or services will satisfy agency requirements for follow-on contracts. Additional Information: Industry Classification (NAICS) Code is 541511, Custom Computer Programming Services and the Small Business Size Standard is $27.5 million. This acquisition is conducted under the procedures as prescribed in FAR subpart 12-Acquisition of Commercial Items and FAR subpart 13-Simplified Acquisition Procedures. The solicitation document, the incorporated provisions and clauses are those in the Federal Acquisition Circular 2005-76, effective August 25, 2014. The National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a sole source noncompetitive basis to provide the Institutional Review Board (IRB) software, iRIS, for the Division of Intramural Research (DIR) to iMedRIS Data Corporation, 446 Missouri Court, Redlands, CA, 92373-8083. The determination by the Government to award a purchase order on a sole source noncompetitive basis to provide the Institutional Review Board (IRB) software, iRIS, to iMedRIS Data Corporation, 446 Missouri Court, Redlands, CA, 92373-8083, is based upon the market research conducted in accordance with one or more of the techniques specified in FAR Part 10-Market Research, Subpart 10.002(b)(2). 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 October 16, 2014 at 12:00 p.m. EST. Responses must reference synopsis number HHS-NIH- NHLBI-CSB-HI-2015-008-CDB, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 6701 Rockledge Drive, Suite 6121A, Bethesda, Maryland 20892-7902, Attention: Chris Bocus. Response may be submitted electronically to chris.bocus@nih.gov. Faxes will not be accepted. 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/HHS-NIH-NHLBI-CSB-HI-2015-008-CDB/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03547946-W 20141011/141009235416-fe08c17542f12e64559c30b34d8d2001 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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