Clinical Trials and Information Management Support (CTIMS)

Added: Dec 15, 2015 3:24 pm
THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.

The NCI's Division of Cancer Treatment and Diagnosis' Cancer Therapy Evaluation Program (CTEP) is responsible for the administration, coordination, and scientific review of most of the extramural clinical trials supported by the Division of Cancer Treatment and Diagnosis (DCTD). These programs include the activities of the NCI National Clinical Trials Network (NCTN) and the Experimental Therapeutics Clinical Trials Network (ETCTN). Many of these trials require scientific review, input and coordination with other DCTD programs (e.g. Cancer Diagnosis Program (CDP) and Cancer Imaging Program (CIP)) and NCI programs such as NCI's Center for Cancer Research (CCR) and the Division of Cancer Prevention (DCP).

CTEP continues to implement recommendations made by the Clinical Trials Working Group (CTWG) of the National Cancer Advisory Board (NCAB) and the Institute of Medicine (IOM) report on restructuring the NCI's clinical trials enterprise to realize the promise of molecular oncology in the 21st century. NCI's Coordinating Center for Clinical Trials (CCCT) guides and facilitates the implementation of the CTWG recommendations. CTEP and the Division of Cancer Prevention (DCP) collaborate with CCCT in the operations of Scientific Steering Committees (SSCs). The SSCs function to enhance scientific quality and prioritization of NCTN clinical trials and DCP's NCI Community Oncology Research Program (NCORP) symptom management, cancer control and cancer care delivery studies.

NCI also supports several precision medicine studies that are developed and implemented nationally and include collaborations with CDP, Center for Cancer Genomics (CCG) and other NCI Divisions and Centers to conduct these studies, including but not limited to the Exceptional Responders study, Molecular Analysis for Therapy Choice (MATCH), Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST), and LUNG-Map.

The Government is seeking a Contractor to provide direct organizational and information management support for these clinical trials programs and to provide support to the CTEP and DCTD Professional Staff in the acquisition, review and analysis of data to assist in the development, planning and conduct of new clinical trials and information which results from completed extramural research.

The work is divided into five major Sections. Organizations will be required to:

I. Contract Transition (Phase-In)

II. Clinical Trials Information Support

The Contractor shall provide support to the NCI Professional Staff in the acquisition of information and analysis of data to support developing new studies. These contract staff, referred to as Information Specialists, will also assist in analysis of data that result from clinical research and other program analyses needed. The data for possible analyses has had the personal identifying information (PII) removed by the NCI grantees prior to data submission to the NCI as part of their standard procedures. Many of these activities support NCI's mission of evaluating, prioritizing, coordinating, and analyzing planned and ongoing clinical trials and clinical research through mechanisms such as concept evaluations, scientific strategy and program meetings, clinical trial planning meetings, and special drug development meetings.

III. Clinical Trials Project Management

The Contractor shall provide clinical trials project management support across four-sub-task areas. These contract staff, referred to as Clinical Trials Project Managers (PMs), shall work collaboratively with NCI Professional Staff to:

A. Coordinate, Track and Support Accrual to CTEP-Sponsored Trials from Activation to Completion
B. Provide Project Management Support and Coordination to DCTD Correlative Science Studies (CSS)
C. Provide Project Management to NCI Precision Medicine Trials
D. Provide Project Management support to NCI's Early Drug Development Project Teams (PT)

IV. CCCT Scientific, Administrative and Logistical Meeting Support
Scientific, administrative, and logistical support for CCCT is broken into four task areas:

A. Scientific Steering Committee Support
B. Task Force Support
C. Working Group (Ad-hoc) Support
D. Additional Administrative Support for Related Activities

V. Options

A. Increased Capacity
B. Phase-Out Transition

The NCI seeks continuation of services to be acquired through full and open competitive procedures under NAICS 541990. It is anticipated that a cost-reimbursement, completion-type contract with a base period of one (1) year, four (4) one year option periods and five (5) Increased Capacity Options may be awarded beginning on or about May 1, 2016.

The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.

Contracting Office Address:
9609 Medical Center Drive
Bethesda, Maryland 20852

Primary Point of Contact:
Charlotte McCormack
Contracting Officer
Charlotte.mccormack@nih.gov
Phone: 240-276-5409

Secondary Point of Contact:
Rukshani Levy
Contracting Officer
Rukshani.levy@nih.gov
Phone: 240-276-5425