SOURCES SOUGHT
R -- Clinical Trials Electronic Data Capture-Adverse Events reporting integration
- Notice Date
- 8/27/2012
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- DOI, National Business Center, AQDDivision 2/ Branch 2381 Elden StSuite 4000HerndonVA20170
- ZIP Code
- 20170
- Solicitation Number
- D12PS00616
- Response Due
- 9/10/2012
- Archive Date
- 10/10/2012
- Point of Contact
- Kimberly Luke
- E-Mail Address
-
kimberly_luke@nbc.gov
(kimberly.luke@aqd.nbc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Department of Interior (DOI) Acquisition Services Directorate (AQD) on behalf of the National Cancer Institute (NCI) is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for Clinical Trials Electronic Data Capture-Adverse Events reporting integration. The result of this market research will contribute to determining the method of procurement for a subsequent acquisition. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541690 with a size standard of $14 million. This is NOT restricted to small businesses. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, response to this notice will not be considered an adequate response to a solicitation. Marketing brochures and/or generic company literature will not be considered. Submissions shall be submitted electronically and shall not exceed five (5) pages. Paper copies will not be accepted. Late responses will only be accepted if they demonstrate extraordinary value to the Government. The responses must include the business size of the vendor under NAICS code 541690 (Service Disabled-Veteran Owned Small Business, Veteran-Owned Small Business, Women-Owned Small Business, HUBZone Small Business, Small Disadvantaged Small Business, Historically Black College and University/Minority Institution, Small Business Joint Venture, Consortium, Team Partnering, or Large Business). Submissions should be in a Microsoft Office compatible format (i.e., Microsoft Word, PowerPoint, Excel, etc.) or Adobe Acrobat and should not contain text smaller than 12 font. The maximum file size of the submission shall not exceed 8 MB. Tables, graphs, etc. will count against the total page count. Font size smaller than 12 may be used to label tables and graphs, but may not be smaller than 8 font. All data received in response to this Sources Sought Notice that are marked or designated as corporate or proprietary information will be fully protected from release outside the Evaluation Panel. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organizations qualifications to perform the work. Respondents are advised that the Government is under no obligation to provide feedback to respondents with respect to any information submitted. No 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). Please be advised that all submissions become Government property and will not be returned. All Government and contractor personnel reviewing RFI responses will have signed non-disclosure agreements and understand their responsibility for proper use and protection from unauthorized disclosure of information as described in 41 USC 423. The Government shall not be held liable for any damages incurred if proprietary information is not properly identified. No telephone calls will be accepted requesting a bid package or solicitation. There is no bid package or solicitation. In order to protect the procurement integrity of any future procurement, if any, that may arise from this announcement, information regarding technical point of contact will not be given and no appointments for presentations will be made. Please refer all questions/comments to the Contracting Officer, Ms. Kimberly Luke, Kimberly_luke@nbc.gov. FedBizOps will be the sole repository for all information related to this RFI. Vendor questions and Government responses will be posted to FedBizOps. No questions will be addressed via oral communication. If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, DUNS, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements. The government will evaluate market information to ascertain potential market capacity to 1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with tight program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; and 4) provide services under a performance based service acquisition contract. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION. More than one solicitation may be issued as a result of this market research. Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 5:00 PM eastern time on September 10, 2012. All responses under this Sources Sought Notice must be emailed to the Contracting Officer, Kimberly Luke at Kimberly_Luke@nbc.gov Instructions The National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology (CBIIT) is requesting information from developers of clinical trials management software on adverse-event reporting. Specifically, NCI is seeking information about the automation and integration of adverse-event reporting with clinical trial electronic data capture (EDC) systems. This is a Request for Information only. Do not submit a proposal or quote. Interested parties are invited to review the information below and to make comments or suggestions. Nothing in this document should be considered binding nor does it obligate NCI CBIIT to conduct any future activities (including procurements). Background and Goals Clinical trials generate large amounts of structured data, much of which is captured and managed in EDC (Electronic Data Capture) systems. Although EDC systems capture data related to adverse events they do not necessarily implement the business rules that the NCI utilizes to define the subset of Serious Adverse Events (SAEs) that need to be reported on an expedited schedule. The facilitation of expedited SAE reporting directly from EDC systems would greatly simplify and improve clinical trial management. In 2012, the NCI began the process of deploying Medidata Rave as the primary Clinical Data Management Systems (CDMS) for NCI cooperative groups. (Medidata Rave is also available to cancer centers and other parts of the NCI supported clinical research enterprise). The government is therefore seeking information on COTS (commercial off-the-shelf) products that could be used to integrate Rave and other CDMS systems with caAERS (Cancer Adverse Event Reporting System [https://wiki.nci.nih.gov/display/caAERS/caAERS]) for the purpose of expediting SAE reporting for the cooperative groups initially, but subsequently could be leveraged by the wider cancer research community. Of particular interest is information describing the manner in which the system is integrated with caAERS and how the SAE business rules are defined, particularly with regard to management of changes in these rules over time. Information Requested NCI CBIIT is interested in learning about available solutions that can package a configurable E2B file from Rave and transmit to caAERS. Additionally, these solutions should include configurable business rules and auditing capabilities. The goal of this RFI is to identify solutions for EDC to adverse-event reporting system integration. These solutions must currently be in production and verifiable by an independent client. Experience: Describe the direct experience your organization has with the integration of EDC systems with adverse-event reporting systems, specifically Medidata Rave. Please be specific about the role of your organization in the initiative(s) and the initiative(s) current status. General Information The following requirements are of particular interest to NCI CBIIT. Responses must meet the minimum requirements described below. Minimum Requirements 1. The solution is currently in production and verifiable by an independent 3rd party client. 2. The solution integrates with Rave. 3. The solution maps to E2B XML format. 4. The solution has integrated business rules functionality including isolation and refinement of data transmitted. 5. The solution has auditing capabilities. Optional Requirements 1. The solution integrates with other EDC systems. 2. The solution manages queries to facilitate reconciliation.
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