National Cancer Institute, Research Contracts Branch, TCS, 6120 Executive Blvd, Room 603, MSC 7220, Bethesda Md 20892-7220

R -- CLINICAL TRIALS MONITORING SERVICE SOL N02-CM-87020-26 DUE 021298 POC Carolyn L. Swift, Contracting Officer, 301-435-3819 and/or FAX 301-402-6699 WEB: Research Contracts Branch Solicitation Website, http://rcb.nci.nih.gov/RFP.HTM. E-MAIL: Carolyn L. Swift, cs102w@nih.gov or swiftc@rcb.nci.nih.gov. The Cancer Therapy Evaluation Program (CTEP) is requesting organizations to submit proposals which will provide a Clinical Trials Monitoring Service (CTMS) for the Cancer Therapy Evaluation Program and other selected investigators using Division of Cancer Treatment and Diagnosis (DCTD) sponsored investigational agents. This service shall have five components: 1) to provide a central data management resource for DCTD and for clinical investigators conducting Phase 1 and selected Phase 2 clinical trials; 2) to provide an on-site monitoring resource for the DCTD to assure that cooperative agreement holders and other clinical investigators conducting Phase 1 and selected Phase 2 clinical trials are in compliance with Federal regulations, policies, and procedures and to verify submitted data and assure protocol compliance; 3) to assure the DCTD that quality assurance programs of the Cooperative Groups, Community Clinical Oncology Program (CCOP) Research Bases and other selected multi- institutional consortiums are actively monitoring their NCI sponsored clinical studies in compliance with the "Guidelines for Monitoring of Clinical Trials for Cooperative Groups and CCOP Research Bases" (this shall be accomplished by attending as co-site visitors, scheduled audits conducted by Cooperative Group, Cancer Center CCOP Research Bases or selected consortiums); 4) to assure the DCTD that all cancer centers or single institutions participating in clinical trials using DCTD sponsored trials are in compliance with Federal regulations, policies and procedures (this oversight shall be accomplished by auditing at these institutions at least once every three years); and 5) to assure the DCTD that foreign groups/institutions who are collaborators in DCTD sponsored clinical trials are conducting these trials in accordance to Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) standards (this shall be accomplished through training and administrative support for quality assurance programs). The Government's requirement over a period of five years is 56.5 FTEs(approximately 11.30 FTEs/year). This proposed acquisition is a recompetition of an existing contract, N02-CM-37829 awarded to Theradex, Inc. The Government anticipates that one (1) contract will be awarded on an incrementally funded basis for a period of five years. This acquisition has been designated as a 100% small business set-aside. The solicitation is scheduled for electronic release approximately December 12, 1997. The RFP may be accessed through the Research Contracts Branch Home Page by using the following internet address: http://rcb.nci.nih.gov/RFP.HTM. It is the offerors responsibility to monitor the above Internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Carolyn L. Swift, Contracting Officer @ e-mail: cs102w@nih.gov; FAX: 301-402-6699; TELE: 301-435-3819. No collect calls will be accepted. See Numbered Note 1. (0330)

Loren Data Corp. http://www.ld.com (SYN# 0071 19971201\R-0012.SOL)