Operation and Support of the Cancer Therapy Evaluation Program's (CTEP's) Protocol and Information Office

The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute's (NCI's) Division of Cancer Treatment and Diagnosis (DCTD) has a continuing requirement for providing the operation and support of CTEP's Protocol and Information Office. The mission of the PIO support contract is to coordinate all administrative aspects related to clinical trial development, in order to ensure that quality protocols are developed in the most expeditious and efficient manner possible. To that end, the Contractor collects, processes, tracks and monitors all protocol-related information between CTEP and its extramural collaborators (investigators, Cooperative Groups, Cancer Centers, FDA, pharmaceutical industry, other NCI programs, etc.). Utilizing various database and document tracking/review applications, the Contractor electronically tracks protocols from the first submission of the idea--termed a letter of intent (Phases I and II) or concept review (Phase III)--through the review process and on through the conduct of the study (monitoring data, amendments, toxicity alert letters) to final completion. In addition, the Contractor abstracts various milestones, which are utilized by the CTEP-Enterprise System (CTEP-ESYS) to track and identify a document throughout its life cycle.



The purpose of the PIO support contract is to:



Facilitate the development of quality clinical trials in the most efficient and expeditious manner possible;



Minimize the administrative burden related to clinical trial development and management on CTEP staff and the extramural community;



Utilize various database and document tracking/reviewing applications to electronically track a protocol throughout its lifecycle;



Abstract key information, including data elements, milestones and treatment descriptors into the CTEP-ESYS, to facilitate informed and timely Program decision making;



Promote, inform and educate all concerned parties regarding NCI programs, policies and objectives that are related to clinical trial development and management; and



Support the CTEP staff and external community with various reports (both scheduled and ad-hoc) to assist in various activities, including timeline analyses, resource allocation, goal-setting, etc.





The Government will provide a suite at CTEP (6130 Executive Blvd., Room 7000, Bethesda, MD 20892), which is comprised of two offices and eight cubicles for all Contractor staff working on-site on this project. All on-site Contractor staff will have at their workstation a computer and phone as well as access to printers, copiers, fax machines, and scanners in order to complete the tasks specified in the Statement of Work (SOW). The Contractor shall monitor the office supplies needed to provide the tasks specified in the SOW. The Contractor shall request equipment and supplies, as needed, to the Project Officer. This is a re-competition of a previous requirement and the incumbent Contractor is IQ Solutions, Inc. (under Contract No. N02-CM-27011, which is scheduled to expire on February 28, 2009). The NCI plans to award a single, incrementally funded, cost-reimbursement, cost-plus-award-fee, type contract for a seven (7) year period. The Governments estimated requirement is 11,880 labor hours per year, for a total of 83,160 labor hours over the total 7 year period. The anticipated solicitation issue date is approximately 15 calendar days after the publication date of this notice, and proposals will be due approximately 30 calendar days after the solicitation issue date. The NAICS code is 541990. The solicitation is open to all eligible members of the 8(a) program of the Small Business Administration; the procurement is being issued as an 8(a) set-aside. The RFP may be accessed through the Office of Acquisitions (OA) home page, by using the following Internet address: http://rcb.cancer.gov/rcb-internet/appl/rfp/published_rfps.jsp . IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE INTERNET SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. Numbered note 26 applies. Point of contact is John R. Manouelian; electronic mail address: manouelj@mail.nih.gov ; telephone: 301-435-3813; fax: 301-402-6699. Collect calls will NOT be accepted.