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FBO DAILY ISSUE OF FEBRUARY 27, 2005 FBO #1189
SOLICITATION NOTICE

R -- Web-Based Data Management System Support Service for FDA Regulated Phase III Clinical Trial

Notice Date

2/25/2005
 

Notice Type

Solicitation Notice
 

NAICS

541511 — Custom Computer Programming Services
 

Contracting Office

US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
 

ZIP Code

21702-5014
 

Solicitation Number

W81XWH05T0295
 

Response Due

3/14/2005
 

Archive Date

5/13/2005
 

Small Business Set-Aside

Total Small Business
 

Description

This synopsis is prepared in accordance with Federal Acquisition Regulation (FAR) Part 5  Publicizing Contract Actions. The synopsis is for web-based data management system support services of a Food and Drug Administration (FDA) regulated Phase II I clinical trial, conducted at multiple sites within the Continential United States and possibly at foreign locations. The services are determined to be nonpersonal in nature in accordance with FAR Part 37  Service Contracting. It is anticipated that th e Government will prepare the solicitation using FAR Part 12  Acquisition of Commercial Items, and FAR Part 13  Simplified Acquisition Procedures. The North American Industry Classification System (NAICS) is : 541511/$21M. The requirement is 100% set aside for small business. The Government anticipates the solicitation to be released using Performance Based Service Acquisition (PBSA) procedures, and award as a fixed price all-or-none contract. The Government anticipates the evaluative critieria to be technical, experience, past performance, and price, with award to be made based on best value to the Government. The period of performance is anticipated to be 43 months; however, there is a possibility that the trial, along with the data management syst em for support, could be stopped at any time for safety concerns if deemed necessary by the FDA, the Data Safety Monitoring Board, the Institutional Review Board (IRB), the Department of Defense (DoD), or the Prinicipal Investigator (PI) for the research t rial. The Government anticipates the period of performance breakout as follows in order to follow the period of performance estimated for each Phase of the clinical trials: base period from contract award through a 2 month period (Phase I); option one for a 5 month period (Phase II); option two for a 12 month period (Phase III); option three for a 12 month period (Phase III); option four for a 3 month period (Phase IV); and option five for a 9 month period (Phase V). The solicitation is estimated to be rel eased on or about 14 March 2005. The Government anticipates the following to be provided with the quotation: Security, Quality Control, Project, and Training plans. The Government anticipates requesting the presentation of a pilot demonstration, simila r to the data management system proposed. The estimated date of award is expected 31 March 2005. Those interested vendors may download the solicitation upon release from the U.S. Army Medical Acquisition Activity (USAMRAA) website at http://www.usamraa.a rmy.mil Click on the Solicitations tab, and click on the solicitation number for Data Management System support services. Requests by telephone will not be accepted. The solicitation will not be provided by hard copy, fax, or email. All vendors are r esponsible for checking any amendment(s) to the solicitation from the USAMRAA website homepage. It is the vendors responsibility to ensure that the solicitation and any amendment(s) are received from the Internet accurately and in its entirety. Those v endors providing quotations shall be registered with the Central Contractor Registration (CCR) database to be eligible for contract award and payment from any Department of Defense activity. Vendors may register with CCR by calling 1-800-334-3414 or by re gistering online at http://www.ccr.gov Vendors who are not registered in CCR at the time of award will not be considered.
 

Place of Performance

Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD

Zip Code: 21702-5014

Country: US
 

Record

SN00758854-W 20050227/050225212447 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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