A -- Clinical Data Management Support

SMALL BUSINESS SOURCES SOUGHTThe National Institute on Drug Abuse (NIDA) is soliciting capability statements from qualified 8(a) and other small business organizations having interest and in-house ability to perform analyses and write reports for use by a Data and Safety Monitoring Board in the monitoring of safety, performance, and utility of clinical trials. The purpose of the ultimate contract (proposals to be solicited via a separate synopsis and solicitation) is to provide clinical data management and support for the Data Safety and Monitoring Board (DSMB) for the Division of Epidemiology, Services, and Prevention Research (DESPR). Activities under this contract will support the DESPR DSMB in monitoring the safety and integrity of research studies carried out under cooperative agreements (U-10), including the multi-site research cooperative Criminal Justice Drug Abuse Treatment Studies (CJ-DATS). The range of support services encompass the following areas: 1) data analysis: conducting data and interim analysis of safety, performance, and efficacy for clinical trails; 2) report writing: developing an interim study analysis and safety report (including documenting adverse and serious adverse events) for DSMB review; and, 3) consultation: making available statistical consultants to participate in DSMB meetings and provide NIDA consultation related to monitoring of clinical trials. Small Business institutions having interest, capability and experience in undertaking such work must send in capability statements to the Contracting Officer. This Sources Sought Announcement is not a solicitation for formal proposals. The information obtained in response to this announcement only will be used to help NIDA determine the project's degree of competitiveness. Small Business sources should identify themselves as 8(a) organizations, women-owned small businesses, veteran owned small businesses, HUBZone small businesses or other small businesses not included in the above categories. No other information is available at this time. Written responses should be delivered to the NIDA contracting office Point of Contact no later than April 25, 2003.