R -- CANCER CHEMOPREVENTION CLINICAL TRIALS MONITORING AND INFORMATICS SUPPORT

Notice Date

July 23, 2001

Contracting Office

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

ZIP Code

20892

Solicitation Number

N02-CN-15026-39

Point of Contact

Theresa H. Shroff, Contracting Officer, (301) 435-3796

E-Mail Address

Theresa H. Shroff (ts144t@nih.gov)

Description

REQUEST FOR PROPOSALS (RFP) ANNOUNCEMENT. The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) intends to release a Request for Proposals (RFP) to select a contractor to provide monitoring and auditing services for DCP chemoprevention studies and cancer prevention trials and to redesign, develop and maintain an informatics system to support the monitoring and auditing of clinical trials Currently, the DCP manages a continuum of scientific activities including identifying and prioritizing agents with potential for chemoprevention activity, selecting agents for development, performing preclinical studies, conducting Phase I and II testing, and moving promising agents into large Phase III cancer prevention trials. It is anticipated that one (1) level of effort, cost reimbursement contract will be awarded for five (5) years. The North American Industry Classification System (NIACS) code applicable to this procurement is 54169. The task areas are as follows: 1) Monitoring of approximately 70 Phase I, II and III DCP cancer prevention clinical trials including the precise tracking of patient accrual, ongoing assessment of patient eligibility and evaluability, adequate measures to ensure timely submission of data and medical review of individual patients' data, rapid reporting of treatment-related morbidity information and interim evaluation of outcome measures and patient safety information; 2) Auditing of DCP cancer prevention clinical trials including site visits to ensure that DHHS and FDA regulations and DCP policies and procedures for conducting clinical trials are being observed; 3) Providing educational support to staff conducting cancer prevention clinical trials which includes developing educational materials or programs in collaboration with DCP staff to ensure that clinical staff are adequately prepared to conduct the trials in accordance with Federal regulatory and NCI/DCP policies and guidelines and 4) Developing and maintaining a central database to collect, analyze and report clinical data from DCP cancer prevention trials. The APPROXIMATE date for release of the RFP is August 7, 2001. PLEASE NOTE: THE RFP WILL BE ISSUED ELECTRONICALLY AND WILL BE AVAILABLE AT THE FOLLOWING WEBSITE ADDRESS: http://rcb.nci.nih.gov/ under "Current Requests for Proposals". POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE RFP AND AMENDMENTS. No collect calls will be accepted. Point of contact: Theresa H. Shroff, Contracting Officer, phone: (301)435-3796; fax: (301) 402-8579; e-mail: ts144t@nih.gov No collect calls will be accepted.

Record

Loren Data Corp. 20010725/RSOL010.HTM (W-204 SN50S6E3)