SOURCES SOUGHT
D -- TECHNICAL SUPPORT FOR PRODUCTION ROLLOUT OF WEBSDM
- Notice Date
- 7/31/2009
- Notice Type
- Sources Sought
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1057591
- Archive Date
- 8/13/2009
- Point of Contact
- Brenda K Lee, Phone: 301-827-7036, Ted L Weitzman, Phone: 301-827-7178
- E-Mail Address
-
brenda.lee@fda.hhs.gov, ted.weitzman@fda.hhs.gov
(brenda.lee@fda.hhs.gov, ted.weitzman@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of qualified small businesses (including certified 8(a), Small Disadvantaged, HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses). The NAICS Code is 541511. The small business size standard is 25M. The U.S Food and Drug Administration through a Cooperative Research and Development Agreement (CRADA) worked in collaboration with Lincoln Technologies to develop a software tool called the Web Submissions Data Manager (WebSDM). It was designed to provide a user-friendly environment for browsing and reviewing CDISC-compliant clinical trial data. WebSDM functionality includes the capability to: Load and validate data submitted in CDISC SDTM-formatted clinical trials data, including error-checking against SDTM specifications and the implementation guide. Checking includes structural and consistency errors; Integrate and analyze clinical trial data, including the pooling of data across studies; Browse data in a variety of tabular and graphical display formats; Drill down to individual subject data supported with graphical patient profiles using the integrated Data Montage graphs or with built-in links to PPD Patient Profiles. In addition, WebSDM is fully integrated with Lincoln’s Clinical Trial Signal Detection (CTSD) system, which comprises a set of graphical and analytical tools designed to help reviewers to access safety data during the product review. CTSD integrates data from the WebSDM SDTM staging area and performs automated screening for safety issues. CTSD features a graphical Sector Map that provides a “big picture” overview that highlights adverse event terms with higher than expected counts. Terms are grouped according to the MedDRA hierarchy to support pattern recognition. For patients treated with a study drug, terms that appear disproportionately more appear in red; terms more frequent in the comparator or placebo appear in green. FDA’s is interested in techniques/tools that are capable of integrating the data with a comprehensive set of centrally programmed, automated analytical tools that facilitate the validation, management, integration, and analysis of clinical trials data in SDTM-compliant format, and the follow-up auditing of the analyses generated to perform a drug safety review. These tools need to include analytical modules capable of generating adjusted and stable safety signals that are corrected for multiplicity and for small counts. The integrated capability to interactively analyze safety signals in a graphical illustration of the data and the capability of moving quickly from the “big picture” to the “fine details” within individual patients adds a valuable input to the overall process of drug safety evaluation and auditing needed during the regulatory review process. These adjusted and stable safety signals need to be carefully investigated to determine whether information needs to be added to the drug label or if risk mitigation programs are required before a product can be approved. Through its involvement in CRADA to develop this SDTM data management tool, FDA has helped create and test an integrated software tool that is well-suited to the import, validation, and review of clinical study data from new drug and therapeutic biologic product submissions. To achieve the benefits of this tool in the review of standardized clinical trials data, it is necessary to take the next steps with a comprehensive roll-out plan and associated technical support. The objectives of this project are to obtain services for the operation and maintenance of the WebSDM software and to expand use of the WebSDM software throughout FDA. Specific objectives of this requirement are listed below: Project management to maintain and expand the use and functionality of the WebSDM data management software; Application support, including Oracle database maintenance, software upgrades and development support for new and advanced analytical features (such as the ones needed to automatically handle the different study designs in Clinical Trials, and to automatically handle new data domains in SDTM CDISC), and support for advanced and less advanced users; Software change management; Provide periodic on-site and remote training; this training shall include documentation of the statistical methodologies used in the tool for clinical trials safety analysis; Assist with production roll-out of WebSDM. It is anticipated that travel may be required to attend conferences and symposiums to provide interface and attain knowledge necessary for the performance of the requirements. Interested small business offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to perform the specific work as required. Response must directly demonstrate the company’s capability, experience, and/or ability to marshal resources to effectively and efficiently perform the requirement as described above in sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above in compliance with FAR 52.219-14 (“Limitations of Subcontracting”). Failure to definitively address each aspect of the requirement will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to ten pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541511 size standard $25M and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, or a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this announcement will not be returned, nor there any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA, OAGS may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT VIA E-MAIL to Brenda K. Lee at brenda.lee@fda.hhs.gov no later than August 12, 2009 12:00 PM Eastern Time for consideration.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1057591/listing.html)
- Place of Performance
- Address: White Oak FDA Campus and contractor's facility, 10903 New Hampshire Avenue, Sliver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01894600-W 20090802/090731235236-54763f264225d4d3fba243d4234a7916 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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