National Cancer Institute, Research Contracts Branch, PCCS, Executive Plaza South, Room 635, Bethesda, Md 20892

R -- CANCER CHEMOPREVENTION CLINICAL TRIALS MONITORING/COORDINATION SUPPORT SOL n/a DUE 022597 POC Theresa H. Shroff, 301-496-8603. E-MAIL: Theresa H. Shroff, shrofft@rcb.nci.nih.gov. This is a SOURCES SOUGHT Synopsis. The Chemoprevention Branch Clinical Research Program, Division of Cancer Prevention and Control (DCPC), NCI, is seeking SMALL BUSINESS Sources with SIC code 8742 to provide specific services for coordinating activities for implementing, monitoring study conduct, auditing generated data and integrating results of the clinical studies that the Chemoprevention Branch oversees. The Chemoprevention Branch, DCPC, currently oversees more than 80 Phase I, II and III clinical trials of potential chemopreventive agents on which NCI is the IND sponsor. Specifically, the work involves 1) protocol finalization/coordination for approximately 10-15 new protocols per year, preparation of preliminary reviews of draft final protocols, Informed Consent and Case Report Forms, biostatistics and data management for compliance with Good Clinical Practices and regulatory requirements; 2) off-site data auditing and cumulative data review for 80 studies, checking for such factors as adverse events and analytical difficulties/successes; 3) on-site clinical monitoring for 80 studies including maintaining Standard Operating Procedures (SOPs) for monitoring chemoprevention clinical trials, preparing study documentation, training study site personnel, verifying 100% key safety and efficacy data against source documents and managing adverse event reporting by maintaining a 24 hour phone/FAX line to receive reports; 4) off-site clinical monitoring and trial coordinating activities; 5) final data and quality assurance audits (5-10 per year). Typically, the Principal Investigator should have at least 5 years experience in directing chemoprevention projects, particularly as related to managing development of chemopreventive investigational drugs. Project staff should include at least one clinical research associate, a biostatistician and database manager/programmer with experience in SAS applications. Other professional members of the project team should have MS/PhD level training in molecular and cellular biology, pathology, pharmacology, biochemistry and toxicology and demonstrated knowledge of carcinogenesis, biomarker evaluation and chemoprevention. Capability statements from SMALL BUSINESSES ONLY (5 copies) shall include Curriculum Vitae's for staff who are available to be assigned to the project. Submissions should be received at the National Cancer Institute, Research Contracts Branch, NIH, 6120 Executive Boulevard, EPS Room 635, Rockville, MD 20852, Attn: Theresa H. Shroff, no later than 3:00 pm local time on February 25, 1997. This synopsis is for information and planning only and does not constitute a solicitation for bids or proposals and is not to be construed as a commitment by the Government. The Government will not pay for any effort expended in responding to this synopsis. See Numbered Note 25. No collect calls will be accepted. (0036)

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