R -- CANCER CHEMOPREVENTION CLINICAL TRIALS MONITORING AND INFORMATICS SUPPORT

Notice Date

June 14, 2001

Contracting Office

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

ZIP Code

20892

Response Due

July 6, 2001

Point of Contact

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

E-Mail Address

Theresa H. Shroff, Contracting Officer (ts144t@nih.gov)

Description

This is a SOURCES SOUGHT Synopsis. SEE NUMBERED Note 25. 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. The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) is seeking SMALL BUSINESS Sources with NAICS 541690 to provide monitoring and auditing services for the DCP cancer prevention trials, to provide training to site coordinators and Clinical Research Associates (CRAs) regarding the conduct of cancer prevention trials at the clinical sites, and to develop or modify existing database models to collect, analyze, and report the clinical trial data. The DCP manages a continuum of scientific activities including identifying and prioritizing agents with potential for chemopreventive 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. Currently, the DCP is either the financial and/or Investigational New Drug (IND) sponsor of 20 Phase I trials and 50 Phase II and III cancer prevention trials. Specifically, the work involves: 1) Monitoring of 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; adequate measures to ensure timely medical review and assessment 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 scheduling site visits to DCP-sponsored cancer prevention trials (approximately 70 sites) to ensure that DHHS and FDA regulations and DCP policies/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 and providing the information to the sites to ensure that the 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 system will be consistent with Code of Federal Regulations (CFR), NCI informatics standards, relevant industry standards, and applicable Health Insurance Portability Protection Act (HIPPA) standards for data integrity, confidentiality, and security. Staff background should include knowledge of DHHS Code of Federal Regulations, Good Clinical Practice, FDA requirements for study sponsors, NIH and NCI requirements for the conduct of clinical trials including ethical and regulatory requirements; experience in designing and developing efficient systems to create, maintain, and analyze large sets of data collected in accordance with complex research protocols; experience in serving as task/project leaders in a medical research and data management environment. Capability statements from SMALL BUSINESSES ONLY (4 copies) shall include Curriculum Vitae for staff who are available to be assigned to the project. Submissions shall be received at the National Cancer Institute, Research Contracts Branch, NIH, 6120 Executive Boulevard, Executive Plaza South, Room 635, MSC7226, Bethesda, MD 20892-7226, Attn: Theresa H. Shroff, no later than 3:00 pm local time on Friday, July 6, 2001. SEE NUMBERED Note 25. No collect calls will be accepted.

Record

Loren Data Corp. 20010618/RSOL019.HTM (W-165 SN50O9D7)