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iMedris Annual Maintenance and Support and Development Upgrades of the NCIís Electronic Protocol Submission and Institutional Review Board Operations

General Information

Document Type:PRESOL
Posted Date:Sep 05, 2017
Category: Automatic Data Processing and Telecommunication Services
Set Aside:N/A

Contracting Office Address

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

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 1E144, Bethesda, MD 20892, UNITED STATES. Description: National Cancer Institute (NCI), Center for Cancer Research (CCR)/Office of the Clinical Director (OCD) plans to procure on a sole source basis the services for iMedris annual maintenance and support and development upgrades, as described below, from iMedRIS Data Corporation; 446 Missouri Court; Redlands, CA 92373. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial acquisitions, and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541512 and the business size standard is $27.5M. This will be awarded as a firm fixed price type contract. The award will be in the aggregate. The period of performance will be twelve (12) months from effective date in the award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Office of the Clinical Director serves as the interface between the CCR and the NIH Clinical Center, the nations largest hospital devoted entirely to clinical research. The NIH Clinical Center includes 242 in-patient beds and 90 day-hospital stations, which house units and clinics where cancer and HIV patients are treated on CCR clinical trials. CCRs Clinical Director, Dr. William L. Dahut, oversees and assures the quality of medical care delivered to patients participating in CCR clinical trials. This office also supports CCRs clinical research program by providing biostatistical expertise for trial design and analysis, administrative support for the protocol review and monitoring process, training of clinical research personnel, an outreach program to promote patient accrual, data management, auditing and monitoring of in-house and multi-institutional trials, and informatics for data collection and storage. In an effort to upgrade the National Cancer Institute Institutional Review Board (IRB), the Office of the Clinical Director (OCD) purchased the Integrated Research Information System (iRIS) electronic document management system from the iMedRIS Data Corporation in the fall of 2005. The purpose of this purchase was to transition from a paper-based system to electronic system which improved the quality of clinical research protocol submissions, expedited the review and approval timeline and to increase both institutional and individual study compliance of all research activities that fall under the Protection of Human Subjects -45 CFR 46 (Office of Human Research Protections - OHRP and 21 CFR 50 and 56 (Food and Drug Administration - FDA). The system has been implemented. Upgrades and maintenance are required on an ongoing basis as the expected level of performance and level of use has risen significantly. The electronic submission process has already greatly increased the consistency of submissions and established increased quality control over both business and regulatory processes. It has streamlined workflow and increased capacity and functionality while at the same time reducing redundancy. The overall project objective is to maintain and upgrade the IACUC electronic protocol submission review and approval module and to continue to maintain and upgrade the current iRIS IRB assistant modules for protocol review and approval at the Center for Cancer Research (CCR) in iRIS. Thus, the project will have the following specific goals: 1. To streamline all work processes for protocol development, review, approval, and post-approval. 2. To create an electronic workflow that supports the activities of all protocols generated by Principal Investigators and other members of the research teams at the NCI, NHLBI and NCI IACUC. 3. To implement a flexible regulatory compliant and comprehensive electronic protocol submission system that is user-friendly and customer focused. 4. To support the daily operational activities of the CCR Office of Regulatory Affairs. 5. To support activities to reduce the time from review to approval from weeks to days. To provide comprehensive administrative reporting that supports regulatory compliance and quality operations management. 6. To allow upgrades and flexibility within the system for reports and for allowing changes to the submission forms, thus alleviating duplicative work. Contractor shall perform the following tasks: Technical Requirements: Products required: A. IACUC Assistant and IRB assistant Annual Licenses for unlimited use. B. Annual Maintenance and support and development upgrades for all existing modules Services to be purchased: System Support: The Contractor shall provide IACUC Assistant and IRB assistant Annual Maintenance and Systems support for twelve (12) months A. Contractor shall provide system updates as they occur. These updates are provided at no charge to the CCR. B. Contractor shall provide software system maintenance for the IACUC Assistant and IRB Assistant. C. Contractor shall provide software support and helpdesk availability, to include telephone access to technical support, from 8 AM to 5 PM Eastern Time, excluding Federal holidays. D. Contractor shall be available for a one (1) hour bi-weekly teleconference with the NCI Technical Point of Contact, and applicable NIH staff for consultation on outstanding issues with the system. E. Contractor shall respond to tickets placed within the iMedris system within one (1) business day of receipt F. Contractor shall be available during the contract Period of Performance to provide recommendations and guidance for: i. Database architecture ii. Database function iii. Report development Payment Payment shall be made in arrears after delivery, inspection and acceptance of requested technical requirements stated above. Payment authorization requires submission and approval of invoices to the NCI Technical Point of Contact and the NIH Office of Financial Management (OFM), in accordance with the payment provisions in the order. The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) FAR 52.232-25 The services are provided by iMedRIS Data Corp. The proposed source is the only known organization that can perform all of the technical requirements stated above. The proposed Vendors demonstrated expertise in maintaining the IRIS database computer software functionality, updating the software, and design functionality for the NCI Institutional Review Board (IRB)s processes and needs has spanned several years from the databases inception. IRIS is proprietary software owned and developed by iMedRIS Data Corp. Substantial support services contributing to the Programs continuation have been provided by the proposed Vendor and their unique qualifications. Because of the continuing, deadline driven nature of the NCI Institutional Review Board (IRB)s processes, the unique performance qualifications of the needed services are required for maintaining its integrity and quality. A change would be disruptive to the NCIs IRB program productivity and throughput, and would negatively affect the NCI IRBs overall performance. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:45PM EDT, on Sept. 15, 2017. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02RC72703-76 on all correspondence.

Original Point of Contact

POC Catherine Muir, Phone: (240) 276-5434

Place of Performance

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