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FBO DAILY ISSUE OF JULY 20, 2002 FBO #0230
SOLICITATION NOTICE

D -- Integrated Clinical Data and Adverse Events Tracking/Reporting Database Management System to Support the Special Immunization Program (SIP) at USAMRIID.

Notice Date

7/18/2002
 

Notice Type

Solicitation Notice
 

Contracting Office

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

ZIP Code

21702-5014
 

Solicitation Number

DAMD17-02-R-0017
 

Response Due

8/30/2002
 

Point of Contact

Shannyn Scassero, 301-619-2640
 

E-Mail Address

Email your questions to US Army Medical Research Acquisition Activity
(shannyn.scassero@det.amedd.army.mil)
 

Small Business Set-Aside

N/A
 

Description

NA This solicitation is anticipated to be released on or about 1 AUG 02. The Specialized Immunization Program (SIP) at the U. S. Army Medical Research Institute of Infectious Diseases (USAMRIID) requires information technology (IT) for support of its clinica l trials on biodefense vaccines and other medical products. To improve its ability to achieve regulatory compliance, the SIP requires IT support in the collection and storage of clinical data in a relational database management system as well as an advers e event tracking and reporting database management system. The purpose of this acquisition is to procure an integrated Clinical Data and Adverse Events Tracking/Reporting Database Management System to support the Special Immunization Program (SIP) at USAM RIID. Successful implementation of the system must provide the following: A)Software-1)Oracle 8i-based clinical data management solution for the collection, retreval, reporting and storage of clinical research data. Software must be compatible with Wind ows 2000 operating system. Software must meet performance-based criteria including extent of industry adoption. Solution must provide both on-line (web-enabled) and off-line electronic data capture (EDC), and must be capable of using language such as XML to a) facilitate cross-study reporting on a common study volunteer; and b) facilitate integration of other software solutions to be determined as necessary for the operation of the SIP; 2)Oracle 8i-based solution specific for clinical trial adverse event tracking and reporting adverse events during clinical trials, including facilitated coding and regulatory reporting. Item #1 and items #2 must be highly integrated; 3)Solution must include medical data dictionary software and dictionary license for use in clinical research including all standard dictionaries. Software must be highly compatible with or integrated within Item 1 and Item 2; 4)The solution must enable through a compatible software approach for the ?push? of notification of key clinical resear ch events to SIP clinical staff. B)Services- 1)Technical services to design, develop implement, install, qualify and validate 2 clinical protocols for USAMRIID SIP in compliance with all appropriate FDA regulations. The first protocol must be operational within not greater than 4 months of project k ickoff; the second study must be operational within 2 months of the first protocol. Services to provide project management for planning and oversight to ensure well-coordinated and integrated execution of efforts resulting in a fully operational, turn-key system to manage the clinical trials unique to USAMRIID; 2)On-site service support for one year for major failures of all software components with a response time of 1 business day subsequent to notification; 3) Services to provide help desk capabilities between the hours of 6 A.M and 6 P.M. System support to be provided 24 hours per day, 7 days per week. C)Training- Services to provide training for IT support, clinical research, and regulatory personnel in the operation of all software products. The following will be Options: OPTION 1-Additional Services as provided under (B)2 renewable annually; OPTION 2-Additional Services as provided under (B)3 renewable annually; OPTION 3-Iplementation of Additional Trial Services to model, implement, install, qualify and validate an additi onal 4 clinical protocols for USAMRIID SIP in compliance with appropriate FDA regulations. The remaining 4 protocols are 80% similar to the first two trials. IT solutions for these protocols to be made operational within no more than 4 additional months after implementation of first two (2) protocols in # (B)1 above; OPTION 4-Additional Software & Services as an integrated component of the clinical data management solution referred to in (a)1, and associated one-time services such as training, which will permit USAMRIID to design its own electronic clinical studies without further service s from the offeror . A commercial items, firm, fixed price award is anticipated. All responsible sources may submit a proposal, which shall be considered by the Agency.
 

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

SN00120515-W 20020720/020718214214 (fbodaily.com)
 

Source

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

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