Cancer Trials Support Unit (CTSU)

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. Title: Cancer Trials Support Unit (CTSU) The NCI is one of the world's largest public sponsors of clinical trials in cancer, supporting a broad range of prevention, diagnostic, imaging, and treatment studies of new drugs, procedures and multi-modality approaches for oncology patients. Developmental work for new treatments (Phase 1 and 2 trials) has traditionally been carried out in a limited number of institutions while definitive studies comparing new treatments to the standard of care (Phase 3 trials) have required multi-center collaborations. The NCI, through its Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD) and other Divisions/Programs (e.g. Division of Cancer Prevention, Cancer Centers Program), supports multiple sites and investigators in North America to collaborate in multi-center trials/studies (e.g. NCI Cooperative Groups Clinical Trials Program for treatment and radiology imaging, Specialized Programs of Research Excellence (SPORES), Community Clinical Oncology Programs (CCOPs), Minority-Based Community Clinical Oncology Programs (MB-CCOPs), Comprehensive/Clinical Cancer Centers Program, and CTEP Phase 1 and 2 Programs). These NCI multi-center programs each maintain the necessary infrastructure (e.g., scientific committees, statisticians, data managers and quality control monitors) needed to successfully perform clinical trials/studies. The CTSU provides a wide-variety of operational, administrative, regulatory, and logistical support services to NCI multi-center coordinating centers and participating sites. Historically these services were distributed through-out each multi-center coordinating centers. This distributed model was duplicative and inefficient. The CTSU was developed to eliminate duplicative efforts, provide central, standardized support to the NCI multi-center research programs, and improve the efficiency of multi-center trial operations. This acquisition is the re-competition of the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) initiative. The initial CTSU contract (NO2-CM-97024) was awarded in 1999 to Westat, Inc. This contract was re-competed in 2006 and again awarded to Westat, Inc. under Contract No. N02-CM-62212. The scope of this contract is to provide administrative, regulatory, logistical, and information technology support for the Cancer Trials Support Unit (CTSU) to gain operational efficiency for both CTSU and NCTN/MCOs, enhance proficiency, and deliver measurable business value. The Contractor shall build and maintain the operational infrastructure of the CTSU. Historically, the CTSU has provided support for NCI Cooperative Group Clinical Trials Program's clinical treatment trial portfolio https://www.ctsu.org/public/. The CTSU portfolio shall be expanded beyond this portfolio to take advantage of the opportunities and efficiencies for multi-center trial support. In this new award, the CTSU support activities will be broadened to the entire breadth of the clinical trial/study portfolio of the Cooperative Groups including, but not limited to, treatment, prevention, cancer control, imaging, comparative effectiveness and diagnostics which are sponsored by either the Division of Cancer Treatment and Diagnosis or the Division of Cancer Prevention or NCI approved collaborations with those Divisions. In addition, by 03/01/2014, the NCI Cooperative Group Clinical Trials Program shall be transformed into the new NCI National Clinical Trials Network (NCTN) Program as Network Groups. The CTSU shall support the Groups prior to, during, and after their transformation to the NCTN Program. Finally the CTSU shall also provide support to other selected multi-center organizations outside of the NCTN Program including, but not limited to, the NCI Experimental Therapeutic Clinical Trials Network (ET-CTN), also known as the Early Clinical Trials Network (ECTN), supported by the Division of Cancer Treatment and Diagnosis. The goals and objectives of the CTSU initiative are: -Facilitate investigator and research staff participation in selected NCI multi-center programs and their clinical trials/studies. -Increase investigator and patient awareness and enrollment to cancer clinical trials/studies. -Provide standardized, integrated, comprehensive support services to selected NCI multi-center programs. -Identify best practices and streamline or eliminate redundant processes and procedures. -Improve operational efficiency, enhance productivity and deliver products offering measurable business value to selected NCI multi-center programs. The CTSU support activities are highly integrated and complex, and the multiple dependencies require tight process/system integration for project success. It is imperative the support activities are centralized to ensure improved efficiency of multi-center trial operations through improved communication, elimination of duplicative effort, and the development and use of standard systems and procedures. This IDIQ initiative will support the following: Task Area I - Initial Transition Plan The Contractor shall ensure a smooth transition between the incumbent contractor and the new award, if required. The Contractor shall transfer relevant files, records, materials, and data; transition of all activities, transition of all CTSU-Enterprise applications from the incumbent Contractor to a secure server space; ensure continuity of CTSU services and provision of key personnel. Task Area II - Core Services CTSU Core Support Services and the CTSU Enterprise of Systems The CTSU Core Support Services consists of the provision of broad-based, centralized, and fully integrated operational, administrative, regulatory, and logistical support services to all CTSU supported NCI multi-center coordinating centers and participating sites, with a specific sub-set of specialized core services for the new NCI National Clinical Trials Network (NCTN) Program. CTSU Core Support Services sections cover operational efficiency; National Clinical Trials Network (NCTN) Program and Multi-Center Organizations (MCO); NCTN/MCO and Other MCOs and selected trials; project management; institutional and individual (person) roster support; regulatory support; protocol documentation/development support; IT support, maintenance, and development; disaster recovery; maintenance and enhancement of CTSU enterprise applications; system integration; system security; help desk; and other IT requirements. Current CTSU systems involved requiring support include the CTSU website; Regulatory Support System (RSS); Oncology Patient Enrollment Network (OPEN); and Clinical Data Management System (CDMS - Medidata Rave). The specific sub-set of specialized CTSU Core Support Services, primarily for the NCTN, include NCTN compliance tracking and standards development and utilization; NCTN budget tracking; CTSU awareness, education, and training; site auditing; and site data reporting performance tracking. Support for Continuance and Completion of Active Trials/Study Activities The Contractor shall provide support in the continuance and completion of trial/study activities initiated under the incumbent contract. This includes Flex Basic Services, Flex Complete Services, and Site Auditing for the Endorsement Program. -Basic Services: Flex basic services include, but are not limited to, Roster Management, Regulatory Support and CTSU website postings. -Complete Services: Include the Basic services described above as well as comprehensive data management for selected trials. -Site Auditing for Endorsement Program: The Contractor shall provide continued site auditing for trials and sites that qualified for the Endorsement Program that were initiated within the incumbent contract. Sites are audited at least once every 3 years (more frequently if required by CTMB). To accommodate the 3-year audit cycle CTSU provision of qualified auditors may last through the first 36 months of the period of performance of this contract. Development Activities The Contractor shall refine, realign, and optimize CTSU procedures and systems to provide support in expanding the CTSU portfolio of NCI multi-center programs and studies beyond the Cooperative Group treatment program and develop international collaboration administrative best practices. Increased Capacity CTSU may be able to expand their portfolio to activate more trials, expand their membership, or enroll more patients. The Contractor shall provide additional workload and capacity generated by expansion of each section. Final Transition Plan The Contractor shall develop and submit a draft final transition plan for Core Services which will describe the Contractor's strategy for transferring work from this contract to a successor contract, in the event a final transition would be required. Task Area III - New IT Initiatives The Contractor shall assist NCI with the addition of new applications and functionality to the CTSU enterprise. Task Area IV - NCTN High Performing Site Initiative (HPSI): The NCI will coordinate the HPSI reimbursements through the CTSU contract as this will provide greater flexibility to address anticipated fluctuations in the eligibility requirements, payment algorithm, schedule, and amount; and with the understanding that HPSI is based on participation across the entire Network rather than participation as a member of a specific Network Group. The Contractor shall assist in this process. Task Area V - NCI Special Initiative Support to NCTN/MCO Organizations and Partners The Contractor shall provide support to special initiatives that fall outside of, the NCTN/MCO organization and partners' grants and contracts. Task Area VI - Data Management The Contractor shall assist NCI by providing data management, regulatory, and operation support for selected NCI and/or NCTN/MCO trials. In addition, the Contractor shall provide Clinical Data Management support for selected trails. It is anticipated the services will be acquired through full and open competitive procedures under NAICS 541690. It is anticipated that a multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) type contract will be awarded for performance beginning on or about July 2013. Please note, only one (1) offeror will be awarded a Task Order for Task Area II - Core Services and that multiple offerors will be included in the IDIQ pool for Task Areas III, IV, V and VI and may receive a Task Order. Offerors must submit a proposal for all Task Area's in order to be considered for award. As part of the Mandatory Criteria, Corporate or project specific IT activities must be Capability Maturity Model Integration (CMMI) level 2, or higher. Offerors are required to provide a CMMI certification at time of proposal submission. The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. 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