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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 08, 2016 FBO #5403
DOCUMENT

D -- 37170 - Complion FDA Submission System - Attachment

Notice Date

9/6/2016
 

Notice Type

Attachment
 

NAICS

541519 — Other Computer Related Services
 

Contracting Office

Department of Veterans Affairs;Technology Acquisition Center;23 Christopher Way;Eatontown NJ 07724
 

ZIP Code

07724
 

Solicitation Number

va11816q1394
 

Archive Date

10/31/2016
 

Point of Contact

Amanda J Bleses
 

E-Mail Address

5-1054<br
 

Small Business Set-Aside

N/A
 

Award Number

NNG15SD22B VA118-16-F-1377
 

Award Date

9/1/2016
 

Awardee

FOUR POINTS TECHNOLOGY, L.L.C.;14900 CONFERENCE CENTER DR STE 100;CHANTILLY;VA;20151
 

Award Amount

$212,039.53
 

Description

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY 1. Contracting Activity:Department of Veterans Affairs (VA) Office of Acquisition Operations Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724 2. Description of Action: The proposed action is for the issuance of a Firm-Fixed-Price Delivery Order (DO) under the National Aeronautics and Space Administration (NASA) Solutions for Enterprise-Wide Procurement (SEWP) V Governmentwide Acquisition Contract (GWAC). 3. Description of the Supplies or Services: VA, Office of Information and Technology, Cooperative Studies Program (CSP), Clinical Research Pharmacy Coordinating Center (CRPCC) has a requirement for brand name Complion computerized electronic software application system and maintenance for the Food and Drug Administration (FDA) approved Regulatory Quality Assurance System which includes a Regulatory Submissions e-System and Quality Assurance Monitoring e-System for clinical research. Additionally, onsite implementation for the Complion system is required. The period of performance for the software licenses and onsite implementation shall be 12 months from date of award. The period of performance for the software maintenance shall be 12 months from date of award followed by four 12-month option periods. 4. Statutory Authority: The statutory authority permitting this exception to fair opportunity is Section 41 U.S.C. 4106(c)(2) as implemented by the Federal Acquisition Regulation (FAR) 16.505(b)(2)(i)(B) entitled, "Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized." 5. Rationale Supporting Use of Authority Cited Above: Based on market research, as described in section 8 of this document, it was determined that limited competition is available among resellers of the required Complion software licenses, onsite implementation, and software maintenance support services. Only Complion offers filing of reports to the FDA using current eFiling methods using the FDA's eSubmission Gateway (ESG) as well as support for future models. Complion provides a single "gatekeeper" security certificate (i.e single user sign-on) for the FDA ESG to allow CRPCC users to submit regulatory packages from the Quality Assurance System to the FDA ESG without accessing the FDA system directly. This gives CRPCC batch filing options using a single electronic certificate. Complion also allows CRPCC to create a document repository for Good Clinical Practices documentation for study teams with functionality for capturing, storing, versioning, and conversion of various in-house working document types to FDA compatible portable document format and allows group-based permissions for the document repository for security and auditing purposes. No other software or software maintenance support is interoperable or compatible with the currently fielded system. Additionally, only Complion, or its authorized resellers, are capable of fulfilling the Government's requirements for Complion software licenses and software maintenance due to the proprietary nature of the software. Sources other than Complion or an authorized reseller would be unable to provide the required software, onsite implementation, and software maintenance due to the fact that only Complion or an authorized reseller is able to access and support the proprietary software code to implement specific software upgrades, patches, bug fixes, and revision upgrades. Failure to acquire brand name Complion software and software maintenance would impact VA's ability to retrieve critical research data stored in the current storage infrastructure. 6. Efforts to Obtain Competition: Market research was conducted, details of which are in section eight of this document. The market research did not yield any other products that can meet the Government's technical requirements. Although the Government is limiting competition as a result of specifying Complion brand name software application system, there are multiple resellers of this product that hold current NASA SEWP V contracts. In accordance with FAR 5.301 and 16.505(b)(2)(ii)(D), the resulting notice of award will be synopsized and this justification will be made publicly available on the Federal Business Opportunities website within 14 days of award. In addition, in accordance with FAR 16.505(a)(4)(iii)(A)(2), this justification will be posted with the solicitation on the NASA SEWP web site. 7. Actions to Increase Competition: In order to remove or overcome barriers to competition in future acquisitions for the requirements described herein, the agency will continue to perform market research to ascertain if there are changes in the marketplace that would enable future actions to be competed. 8. Market Research: Government subject matter experts conducted market research in April and May of 2016 by reviewing the technical specifications of FDA identified ESG compatible software solutions. The Government's subject matter experts determined that only Complion software licenses, onsite implementation, and software maintenance can meet the Government's infrastructure interoperability and software compatibility requirements. Additionally, VA's technical experts regularly review industry trade publications and white papers, consult with industry subject matter experts, and conduct internet research to ascertain if any other software is available in the marketplace that can meet the Government's requirements. Based on all of these market research efforts, the Government subject matter experts have determined that only Complion brand name software can meet all of VA's technical requirements. Additional market research was conducted by the Contract Specialist in August 2016 by conducting a Request for Information (RFI) via the NASA SEWP V GWAC to ascertain the extent of limited competition among resellers and to see if there were any other software solutions that could meet VA's requirements. Two responses were provided from Four Points Technology and Emergent. It was determined by the Government subject matter expert that Emergent provides automatic filing but does not have the capability to provide single user sign-on nor FDA compliant record management folders. Four Points Technology completely meets VA's requirement. Additionally, market research was conducted in August 2016 utilizing the NASA SEWP V GWAC Provider Look-up tool. The results of the Provider Look-up tool search found that Four Points Technology, a Service-Disabled Veteran-Owned Small Business is the only reseller of Complion products on the NASA SEWP V GWAC. Furthermore, the Contract Specialist contacted Complion directly and confirmed that Four Points Technology is the only current reseller of Complion products. 9. Other Facts: None.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/3f046d8866ec1dc54326c8d9a26ebf48)
 

Document(s)

Attachment
 

File Name: NNG15SD22B VA118-16-F-1377 NNG15SD22B VA118-16-F-1377_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2988900&FileName=NNG15SD22B-032.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2988900&FileName=NNG15SD22B-032.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04257949-W 20160908/160907173745-3f046d8866ec1dc54326c8d9a26ebf48 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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