SOLICITATION NOTICE
R -- Clinical Trials Monitoring Service
- Notice Date
- 9/4/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-27043-23
- Response Due
- 11/14/2002
- Point of Contact
- Doris Rosenblatt, Contracting Officer, Phone (301) 435-3824, Fax (301) 402-6699,
- E-Mail Address
-
dr220a@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Cancer Institute is seeking a Clinical Trials Monitoring Service to assist the Cancer Therapy Evaluation Program, NCI in fulfilling its regulatory responsibilities as an IND sponsor. The Contractor shall be responsible for the following tasks: (1) To provide a central data management and data capture resource for the Division of Cancer Treatment and Diagnosis (DCTD) and for clinical investigators conducting Phase 1 and selected Phase 2 clinical trials. (2) To provide an on-site auditing 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, assure protocol compliance, and assure patient safety through proper reporting. (3) To assure the DCTD that quality assurance programs of the Cooperative Groups, Community Clinical Oncology Program (CCOP) Research Bases, the Clinical Trials Support Unit (CTSU), 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, CCOP Research Bases, and CTSU". This shall be accomplished by attending as co-site visitors, scheduled audits conducted by Cooperative Group, Cancer Center CCOP Research Bases, the CTSU or selected consortiums. (4) To assure the DCTD that all cancer centers or single institutions conducting clinical trials using DCTD sponsored trials are in compliance with Federal regulations, policies and procedures. This oversight shall be accomplished by on site auditing at these institutions at least once every three years. (5) To assure the DCTD that international 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. It is anticipated that the effort required for this contract will be 156.1 productive FTEs over a period of seven years (22.3 FTE's per year). The proposed acquisition is a re-competition of contract N02-CM-87020 award to Theradex Systems, Inc. The Government anticipates that one (1) contract will be awarded on an incrementally funded basis for a period of seven (7) years. This contract will be awarded as a Cost Reimbursement contract with award term incentives. This acquisition has been designated as a 100% small business set-aside under NAICS Code No. 514210 with a size standard of $21 Million. (See Numbered Note 1.) The solicitation is scheduled for electronic release approximately September 30, 2002. The RFP may be accessed through internet address: http://rcb.nci.nih.gov/. It is the offeror's responsibility to monitor the above internet site for the release of this Solicitation and Amendments, if any. POTENTIAL OFFER'S WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Doris Rosenblatt, Contracting Officer at e-mail: dr220a@nih.gov/ FAX:301-402-6699; Telephone 301-435-3824. No collect calls will be accepted. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (04-SEP-2002). IT ACTUALLY FIRST APPEARED ON THE FEDBIZOPPS SYSTEM ON 03-DEC-2002. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/RCB/N02-CM-27043-23/listing.html)
- Record
- SN00215056-F 20021205/021203215846 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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