SOLICITATION NOTICE
70 -- iRIS Software
- Notice Date
- 11/2/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541519
— Other Computer Related 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, MD, 20892-7902, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NHLBI-PB-(HL)-2007-009-DDC
- Response Due
- 11/13/2006
- Archive Date
- 11/28/2006
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisitions (OA) DERA, for the Office of Clinical Affairs (OCA Institute Review Board (IRB) intends to negotiate and award a purchase order on a noncompetitive sole source basis to IMEDRIS Data Corporation, Integrated Medical Research Data, 621 E Carnegie Dr., Suite 180, San Bernardino, California 92408. The items to be purchase are: Item (1) IMEDRIS Review Board, quantity one (1) each, the system consists of the following specifications: Review Board Assistant? - web-based, integrated Review Board module giving shall give the site ability to run electronic IRB-only meetings, accept electronic submissions and the ability to monitor study compliance. Generate the IRB, outcome letters and consent form difference. Configuration of 1 IRB review board and up 2 IRB subcommittees must be included with the proposal. Additional review boards must be allowed to be created and added to the workflow. Study Assistant?(partial) - a web-based module which gives the OCA and IRB the ability to electronically capture and submit all study related forms and applications for research. Configure submission routing, key study personnel training and submission sign-off, study status, correspondence with the review boards and fellow researchers. Item (2) Scientific Review web-based, integrated Review Board module giving the OCA and IRB site the ability to conduct electronic review and meetings for a scientific committee. Accept electronic submissions via an integrated workflow. Generate meeting minutes, and outcome letters and reviews summarize through this module. View submission history and outcome from other review boards integrated with your application (IRB). Item (3) Level 2: Configuration Options: Requires an implementation team with hands on involvement with iMedRIS to walk the researchers through the process of configuring the software. Weekly half hour team meetings are included, access to a customer server is required to check progress and help with any specific issues. Item (4) User/Technical Support Technical and customer service support and upgrades shall be included for the first year, with the purchase of the Site Assistant software. The technical/customer service support contract will be 15% of the total contract price, after the first year. This contract includes all upgrades/ enhancements, customer service and licensing agreements for a one year period from the date that the software is installed and/or made available to the customer. Upgrades and enhancements to be no less then twice a year. After a 24-month period, Licensor may increase the maintenance service fee by an amount not to exceed the Consumer Price Index or 5%, whichever is less. The sole source determinations are based on the fact that the NHLBI Office of Clinical Affairs (OCA) and Institute Review Board (IRB) manages the involvement of patient research, which requires many levels of approval and oversight. It is required for the investigators to create and submit a proposed protocol consent forms and an NIH study application (NIH-1195). During the review and approval process, they may be required to submit additional documents, such as radiation safety approval or investigational new drug forms. Once the proposed protocol package is assembled, it is submitted for review and forward to the IRB for possible approval. Approval is contingent upon meeting stipulations from the IRB. During this process, many people may be involved with reviewing, validation and verifying the documents which make up the protocol submission. The iRIS Enterprise software solution has already been implemented by a number of Institutes here at NIH, NCI and NIAID. Prior to the initial implementation the Institutes went through preliminary configurations and engaged iMedRIS to make change to the software required for it to be useful at NIH. Institutes that implement the iRIS software in the future will be able to leverage the time and effort that NCI and NIAID have already invested in making this software compatible with patient research requirements at NIH. While iRIS software is an ?out of the box? solution, it will require time for administrative and technical personnel to configure it to the specific business practices, and for the NHLBI specific forms that are to be used. Based on NCI?s experience, it is estimated there would be a three (3) month configuration period before the initial implementation. The current application in use at NHLBI requires substantial amount modifications and is not compatible with software in use at NCI and NIAID. Therefore, to conduct an award to any other source would result in a substantial duplication of cost to the Government that is not expected to be recovered through competition. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement. The acquisition is being conducted under simplified acquisition, commercial item procedures, and is exempt from the requirements of FAR Part 6. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this requirement. Responses to this announcement, referencing synopsis number ?NHBLI-PB-(HL)-2007-009-DDC? may be submitted to the National, Heart, Lung and Blood Institute, Operations Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6042, Bethesda, MD 20892-7902, Attention: Deborah Coulter. Fax quotations will only be accepted if dated and signed by an authorized company representative.
- Place of Performance
- Address: BETHESDA, MD
- Zip Code: 20892-7902
- Country: UNITED STATES
- Zip Code: 20892-7902
- Record
- SN01174997-W 20061104/061102220316 (fbodaily.com)
- Source
-
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