Cancer Trials Support Unit

Title: Cancer Trials Support Unit (CTSU)

Background:

The National Cancer Institute (NCI) is the federal government's principal agency for cancer research and training. Established under the National Cancer Institute Act of 1937, NCI is part of the National Institutes of Health (NIH), one of the 11 agencies that make up the Department of Health and Human Services (HHS).

NCI’s mission is to lead, conduct, and support cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. As the leader of the cancer research enterprise, collectively known as the National Cancer Program, and the largest funder of cancer research in the world, NCI manages a broad range of research, training, and information dissemination activities that reach across the entire country.

To support this mission, the Cancer Trials Support Unit (CTSU) was launched in 1999 to streamline and harmonize support services for phase three Cooperative Group cancer clinical trials funded by the NCI. Since that time, the scope of the CTSU has expanded to include support of multiple NCI-funded networks plus clinical trials of all phases and types including cancer treatment, prevention and control, advanced imaging, and correlative science studies. The CTSU collaborates with the NCI and the NCI funded Multi-Center Organizations (MCOs) to develop and support operational processes and informatics solutions leading to cost-effective solutions that reduce administrative burden on the clinical sites and accelerate scientific inquiry.

The purpose of this contract is to provide broad-based, centralized and fully integrated operational, administrative, regulatory, information technology (IT), and logistical support services to support the participation of multiple sites both nationally and internationally in multi-institutional cancer trials led by NCI-supported clinical trial organizations.

The contract includes the following Task Areas:

1. Task Area 1: Project Kick-Off Meeting/Transition Activities
2. Task Area 2: CTSU Core Support Services and the CTSU Enterprise of Systems
3. Task Area 3: Awareness, Education, and Training (AET)
4. Task Area 4: Site Study Set-up
5. Task Area 5: Protocol and Scientific Writing Support (PSWS)
6. Task Area 6: Electronic Patient-Reported Outcomes (PROs)

Note: Task Area 1 will be awarded to all vendors selected to be in the multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) pool for each task area.  It is anticipated that NCI will award a base contract to a single contractor for Task Area 2 and multiple contractors for Task Areas 3, 4, 5, and 6.

This acquisition is a re-competition of IDIQ contracts HHSN261201300028I with Westat, Inc. and HHSN261201300029I with PPD. The services related to Task Area 5 are being provided under the contract HHSN261201500006C with Technical Resources Inc.  Some services under Task Area 6 are provided under contract HHSN261201800033I; Task Order HHSN26100001 with Medidata Solutions, Inc.

Please see attached for futher details.