SOLICITATION NOTICE
70 -- IRB Manager Software License, Hosting, Maintenance and Support
- Notice Date
- 1/11/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 511210
— Software Publishers
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CO01416-24
- Archive Date
- 2/9/2016
- Point of Contact
- Kimesha Leake, Phone: 2402765669, Jolomi Omatete, Phone: 2402766561
- E-Mail Address
-
kimesha.leake@nih.gov, jolomi.omatete@nih.gov
(kimesha.leake@nih.gov, jolomi.omatete@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E626, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. N02CO01416-24 includes all applicable provisions and clauses in effect through FAR FAC 2005-85 (December 2015) simplified procedures for commercial items. This acquisition is a 100% small business set aside. The North American Industry Classification System code is 511210 and the business size standard is $38.5 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract with a base plus four option periods. I. Description of Requirement The National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) administers the NCI Clinical Trials Network and Early Therapeutic Clinical Trials Network programs for the performance of cancer treatment and prevention trials. The NCI Clinical Trials Network is comprised of four adult clinical trial organizations and one pediatric organization. The Early Therapeutic Clinical Trials Network is comprised of investigators who conduct clinical trials funded by grant mechanisms. The NCI Central Institutional Review Board (CIRB) reviews NCI-sponsored studies selected by CTEP for human subjects' protections. Site Membership and participation in the CIRB is initiated, tracked and maintained via IRBManager©. The tool assists the CIRB in assuring that regulatory and human subjects protection requirements are met. The CIRB is one of the largest, if not the largest, publically-funded Central IRBs in the U.S. Over 1,000 research sites participate in the CIRB; consequently, the support tool must be able to do more than routine IRB Operations Office processes but must be able to support a Central IRB. This requires a tool that can communicate with participating institutions for enrollment, local context submissions, and opening studies. The tool must have a prior track record of supporting other Central IRBs because this project, while fully functioning, is still growing. IRB Manager is a software product utilized by the Central Institutional Review Board (CIRB) to capture and track site participation in the initiative to meet regulatory and human subject protection requirements. IRB Manager has been tailored to the unique needs of the NCI CIRB and has been integrated with other NCI systems. The CIRB has been accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). AAHRPP accreditation of the NCI CIRB was based in part on the use of best practices and systems including a customized and integrated version of IRB Manager. Scope of Work: The contractor shall be responsible for: • Providing license, hosting and maintenance for a production and test instance of Base Product • Providing license, hosting and maintenance for a production and test instance of a Reporting Server • Provide approximately 60hrs/yr of IT support for system enhancements, customization. • If the system is not integrated with other NCI systems at the time of award then provide 1 FTE in contract year 1 and 0.5 FTE in contract year 2 to integrate with other NCI systems including but not limited to CIRB Website, CTSU's Regulatory Support Service (RSS) and CTEP's Identity and Access Management (IAM). In order to meet current and anticipated needs, the following must be provided: 1) Must be a fully web-based database designed to: • Manage all the aspects of CIRB-related information. • Remind the CIRB administrators of tasks at hand. • Communicate with the local institutions, local investigators and Board members through a common base of information, document generation, document attachments and event tracking. 2) Must allow users to: • Enter protocols and protocol related information such as: investigator, site (supports multiple sites/investigators/research staff), reviewers, events, sponsor/funding source, title, grants manager, category of the study, attachments, approval dates, descriptions, comments, generated documents and statuses. • Attach documents. • Create events associated with either an individual site in a study or all the sites participating in the study 3) Able to customize changes including: • Unique user-defined fields, events, event steps, and reports • Web services to consume and exchange data almost instantaneously between the CIRB website and database, and NCI's Clinical Trial Support Unit (CTSU) and Regulatory Support System (RSS) database, thus supporting: o Pre-enrollment and enrollment functions involving institution and person roster information; o Study determination documentation and institution study-specific approvals to RSS for internal processing and public display on the CTSU website • Send study review outcome data and institution-specific CIRB coverage confirmations to CTSU. • Utilize the NCI's Identity and Access Management (IAM) for system access. • Populate with institutions and person data from RSS to create the appropriate institution-specific person associations. • Customize forms designed to capture local context information for signatory institutions and principal investigators, new study coverage requests, study closure/IRB transfer requests, locally developed materials, and unanticipated problems/serious noncompliance issues as well as a secured loop for document submission, CIRB Operations Office review, and Board determination. 4) Ensure system availability and data integrity including: • Ensure that systems are backed up routinely. The Contractor shall have a process to minimize risk of data loss and disruption of operations. • Work together with NCI to determine the frequency of the back-up schedule and identify back-up prioritization, as both are dependent on the criticality of the system data for each application. • Store and rotate back-up tapes to maximize data integrity, safety, and minimize system downtime. • Provide a proposed maintenance schedule for regular system maintenance to include downtime for maintenance/updates with the least impact to the operations of the systems. The Government anticipates peak hours for all systems to be weekdays from 8:00 AM - 8:00 PM Eastern Standard Time (EST). • Ensure all systems are fully functional 24 hours per day, 7 days per week (except scheduled maintenance). Immediate notification to the Contracting Officer Representative (COR) is required upon realization of any system failure for any reason to include natural or man-made disasters. In the event of a major natural (e.g., weather, etc.) or man-made (e.g., power outages, etc.) disaster causing shutdown of CIRB operations, the Contractor provide a plan and ensure that the system shall be operational within 4 hours and be fully operational within 24 hours. • Work diligently to restore any such failure in the most expedient manner, while providing status updates to the COR until the system failure is resolved. • Provide a detailed back-up plan for system failure to include plans for testing the disaster recovery plan at least twice per year. • Provide a secondary facility, geographically separated from the primary facility, to ensure continuity of NCI CIRB operations. II. Delivery: The Contractor that receives the award will be provided with the complete mailing address and point of contact. III. Payment: Payment shall be made after delivery and acceptance of the product. Payment authorization requires submission and approval of invoice to the NCI COR and NIH Commercial Accounts. QUOTATIONS ARE DUE: January 25, 2016 PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (October 2015); FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (November 2015) WITH DUNS NUMBER ADDENDUM {52.204-6 (July 2013)}; FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (May 2015); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (November 2015). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; FAR Clause 52.203-6 Restrictions on Subcontractor Sales to the Government with Alternate I FAR Clause 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment FAR Clause 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters FAR Clause 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns. FAR Clause 52.219-6 Notice of Total Small Business Set Aside FAR Clause 52.219-8 Utilization of Small Business Concerns FAR Clause 52.219-14 Limitations on Subcontracting FAR Clause 52.219-28 Post Award Small Business Program Representation FAR Clause 52.222-3 Convict Labor FAR Clause 52.222-19, Child Labor-Cooperation with Authorities and Remedies FAR Clause 52.222-21 Prohibition of Segregated Facilities FAR Clause 52.222-26 Equal Opportunity FAR Clause 52.222-35 Equal Opportunity for Veterans FAR Clause 52.222-36 Equal Opportunity for Workers with Disabilities FAR Clause 52.222-37 Employment Reports on Veterans FAR Clause 52.222-40 Notification of Employee Rights, Under the National Labor Relations Act FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases FAR Clause 52.232-33 Payment by Electronic Funds Transfer-System for Awards Management (SAM) FAR Clause 52.239-1 Privacy of Security Safeguards Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://ncioa.cancer.gov/oa-internet/ or from Kimesha Leake, Contract Specialist at Kimesha.Leake@nih.gov OFFERORS: Offers must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror or provide valid certification showing that the offeror is registered in the System for Award Management (SAM) through www.sam.gov Quotations must be received in the NCI-OA contracting office by 1/25/16. Please refer to solicitation number N02CO01416-24 on all correspondence. No collect calls or faxed quotations will not be accepted. Electronic quotations will be accepted at Kimesha.leake@nih.gov All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through sam.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CO01416-24/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E626, Bethesda, MD 20892, UNITED STATES., United States
- Record
- SN03987987-W 20160113/160111234437-db5e08f9c438e5bf224145fb59769fc4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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