SOLICITATION NOTICE
R -- JA 18324 - Package #1
- Notice Date
- 9/28/2018
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 519190
— All Other Information Services
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Archive Date
- 10/26/2018
- Point of Contact
- Peter D. Mitchell, Phone: 3016191355
- E-Mail Address
-
peter.d.mitchell8.civ@mail.mil
(peter.d.mitchell8.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Award Number
- W81XWH-13-F-0036
- Award Date
- 9/26/2018
- Description
- Redacted J&A The USAMRMC eIT PMO is responsible for providing Information Technology (IT) solutions to the USAMRMC in accordance with Department of Defense (DoD) and Army / Medical Command (MEDCOM) policies and regulations. This primary mission includes several major activities: • Actively maintain and manage requirements associated with eIT PMO IT Systems for the USAMRMC. • Acquire, configure, and test IT capabilities to comply with approved requirements. • Establish and maintain applicable Project Baselines. Ensure these are effectively managed with appropriate Acquisition Configuration Management (CM) Control and associated processes capabilities. The eIT PMO currently provides four capabilities in Production: • Electronic Document Management System (EDMS). The EDMS software application is Open Text Corporation's Content Server Management TM Commercial off the Shelf (COTS) product. EDMS provides enterprise content management and supports the storage and submission of Food and Drug Administration (FDA)-regulated electronic records at the USAMRMC. • Serious Adverse Event (SAE) Reporting System. The SAE software application is the Oracle Argus Safety TM COTS product. SAE is used to meet stringent FDA reporting requirements for all SAEs that occur during the conduct of clinical trials. • Electronic Data Capture (EDC) System. The EDC software application is the Oracle (Phase Forward) Inform Global Trial Management TM and Clintrial COTS products. EDC is used to capture and store clinical trials data in databases that meet the requirements specified in 21 CFR Part 11. • electronic Common Technical Document (eCTD). The eCTD software application is the Liquent Insight for Publishing and Liquent Insight for Viewing COTS products. eCTD is used to create electronic regulatory submissions for transfer to the FDA in the required electronic submission format. • Clinical Trial Management System (CTMS). The CTMS software application is the Bioclinica Onpoint CTMS COTS product. This application supports all aspects of clinical trial studies as well as monitoring and regulatory compliance activities. Increasingly, DoD/Army Acquisition requirements involving Information Management/Information Technology (IM/IT) have driven MRMC to more effectively and efficiently identify and manage IT efforts across the command for regulated information systems. Currently the system of COTS products that eIT PMO supports over 700 users, located in the disparate locations of USAMRMC, but primarily Fort Detrick. The eIT PMO mission is carried out almost entirely using contractor support under this contract.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/ec419b7c934bcacda16b23bbfbe44725)
- Place of Performance
- Address: 504 SCOTT STREET, FORT DETRICK, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN05110924-W 20180930/180928231057-ec419b7c934bcacda16b23bbfbe44725 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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