Central Contracting Office MEDCOM, ATTN MCAA C, 2107 17th Street, Building 4197, Fort Sam Houston, TX 78234-5069

D -- ELECTRONIC RECORD SYSTEM FOR SUBMITTING NEW DRUG APPLICATIONS TO FDA DUE 032400 POC Rachael T. Espinoza, 210-295-4912 & Sylvia F. Flores, 210-295-4617 WEB: Click here to download a copy of RFI, http://cbdnet.gpo.gov. E-MAIL: sylvia.flores@cen.amedd.army.mil, rachael.espinoza@cen.amedd.army.mil. DESCRIPTION: Request for Information is as follows: This is a Request for Information (RFI) from potential sources capable of providing a Federal Drug Administration approved and validated New Drug Application Documentation software system that is fully compliant with 21 CFR Part 11. The software system initially is to include all software, hardware requirements, integration strategies, training, maintenance, and licenses required to: a) Submit data electronically into the data base b) Submit data electronically to the Food and Drug Administration c) Convert hardcopy clinical study reports to electronic format d) Provide for high capacity storage and archiving capability e) Delete selective data in active Database f) Provide robust local data entry capability which includes direct support of data collection g) Enable electronic signatures h) Provide security level to meet Privacy Act and Health Insurance Portability Accountability Act requirements. i) Track and handle documents in both soft and hard copy. j) Sort, retrieve, etc the data. k) Quality Assurance and Monitoring capability The system will be installed on an existing government Windows NT network infrastructure at Ft Detrick Maryland and Walter Reed Army Institute of Research, Maryland. In addition, the system must be capable of providing remote access and stand-alone capabilities to support overseas locations. Eventually, the government is interested in completely automating the entire drug development process to include; a) Clinical studies process including the protocol tracking and management b) Volunteer tracking and management c) Individual researcher tracking and management d) Test article numbering and tracking e) Animal studies process and animal tracking f) Drug manufacturing process g) Tying remote sites in using wireless communication devices These processes are ordered in the importance to the government. The government intends to use the information provided to develop a total system acquisition strategy and a Request for Proposal(RFP) that leads to system procurement in the summer of 2000. Responses (both technical and cost) shall be submitted either by e-mail, fax (210)295-4937, or mail to MEDCOM Contracting Center at the following address: MEDCOM Contracting Center, 2107 17th Street, Building 4197, Fort Sam Houston, Texas 78234-5015, ATTN: Rachael Espinoza by 4:00 PM CDST on March 24, 2000. All potential sources are encouraged to include their name and point of contact with their firm, address, e-mail address, phone number and facsimile number. Contractors are also encouraged to include their questions, comments, or concerns. An opportunity for contractors to have face-to-face discussions with government personnel will be made available during April 3 and 4, 2000 at Fort Sam Houston, Texas. Each firm will be allowed 1 1/2 hours to present their questions, comments, or concerns. Sources who have expressed interest in the requirement will be contacted by the MEDCOM Contracting Center personnel to schedule the day and time they will be presenting their questions, comments, or concerns to the government personnel. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP REQUESTS. NO TELEPHONE CALLS REQUESTING A SOLICITATION WILL BE ACCEPTED OR ACKNOWLEDGED. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. Posted 03/10/00 (W-SN433237). (0070)

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