Clinical Trials and Information Management Support (CTIMS)

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.

Title: Clinical Trials and Information Management Support (CTIMS)

Background:

The National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP) is responsible for administration and coordination of extramural clinical trials supported by the NCI’s Division of Cancer Treatment and Diagnosis (DCTD). This includes the activities of the NCI National Clinical Trials Network (NCTN), the Experimental Therapeutics Clinical Trials Network (ETCTN), several smaller trial networks, and the recipients of investigator-initiated grants and cooperative agreements relating to the development of anti-cancer agents and promising new cancer treatments. The Government is seeking a Contractor to provide direct organizational, project management, information management, and logistical meeting support for these scientific and clinical trials programs. In addition, CTEP, DCTD, and the Coordinating Center for Clinical Trials (CCCT) need support in the acquisition, review and analysis of data to assist in the development, planning and conduct of clinical trials and related scientific programs.

This acquisition is a re-competition of contract HHSN261201600002C awarded to the EMMES Company LLC.  Previous contracts for this initiative that was awarded to EMMES include: contract N02-CM-97032 (May 1, 1999 - April 30, 2004), contract N02-CM-42205 (May 1, 2004 to- April 30, 2011); and N02-CM-2011-00010 (May 1, 2011 – April 30, 2016).

Requirements:

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

1. Contract Transition:

During the first 45 days of the contract, the Contractor shall implement a seamless transition, in cooperation with the incumbent, to ensure the knowledge and activities of the contract are transitioned to the Contractor staff.  At the end of the 45 day period, the Contractor shall be able to independently initiate new and maintain ongoing work.

Forty-five days prior to the expiration date of the contract, the Contractor shall ensure an orderly, secure, efficient, and expedient transition of all contract activities to a successor contractor.

2. 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. Contractor staff, herein referred to as Contractor, shall also assist in analysis of data that result from clinical research and other program analyses needed. All Data for analyses is deidentified by the NCI grantees prior to submission to the NCI as part of their standard procedures. 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.

3. Clinical Trials and Scientific Program Project Management

The Contractor shall provide clinical trials project management support across five-sub-task areas. These contract staff, shall work collaboratively with NCI Professional Staff to:

1. Coordinate, Track and Support Accrual to CTEP-Sponsored Trials from Activation to Completion
2. Provide Project Management Support and Coordination to DCTD Correlative Science Studies (CSS), CCCT Scientific Steering Committees, and CTAC
3. Provide Project Management to NCI Precision Medicine Trials
4. Provide Project Management support to NCI’s Early-Phase Development Projects
5. Provide Project Management support to NCI Cancer Moonshot Networks and Projects and other Congressionally Mandated Projects and National Health Emergency Projects.

4.  CCCT Scientific, Administrative and Logistical Meeting Support

The Contractor shall provide scientific, administrative, and logistical support for CCCT as broken into four task areas:

1. Scientific Steering Committee and Task Force Support
2. Clinical Trials and Translational Research Advisory Committee (CTAC) and CTAC Subcommittee Support
3. Working Group (Ad-hoc) Support
4. Additional Administrative Support for Scientific Steering Committee and CTAC Related Activities as needed.

Anticipated Period of Performance:

These Research & Development services will be acquired through Full and Open Competition. It is anticipated that one (1) cost reimbursement contract will be awarded with a one (1) year base plus six (6), one (1) year option periods beginning on or about June 1, 2021. In addition, there will be one option for a Phase-Out of 45 days.

The Solicitation will be available electronically on or around July 29, 2020 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS’ RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL RESPONSIBLE SOURCES, AND 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.