The Food and Drug Administration/National Center for Toxicological Research (FDA/NCTR) has a requirement to purchase a Commercial-off-the-Shelf (COTS) software that will replace an in-house-developed, pre-clinical data (e.g. dosing, clinical observations, animal weights, feed consumption, etc.) collection and management system (CDMS) that was introduced in 1998. Multiple stakeholders will interact with this system in different ways (ex. different modules or via separate applications), so the system needs to fit various scenarios and must be role-based. The overall goal is to have a comprehensive system with increased functionality that can capture and report on animal data from in-life portions of the study through pathology and study closure (archiving).
The CDMS software shall meet the following minimum requirements:
6.1. IT Requirements. The software shall:
- Be hosted on premises at the NCTR Data Center on servers owned and operated by FDA. (i.e. no cloud services).
- Be compatible with and store data and audit information on Oracle Database Version 12 or later. Oracle database licenses will be provided by FDA.
- Be able to use Personal Identity Verification (PIV) badge for access to system.
- Be capable of being hosted on virtual servers running either Red Hat Enterprise Linux v7 or later or Microsoft Windows Server 2012 R2 or later. Operating system licenses will be provided by FDA.
- Be compatible with Citrix 7.15 or later…
This solicitation, identified as FDA-RFP-1209563, is issued as a request for proposals (RFP) in accordance with the requirements of FAR Part 12 and 13.5.
