Clinical Trials and Information Management Support (CTIMS)

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541611in the North American Industry Classification System (NAICS), and the size standard for such requirements is $15.0 Million per annum. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) as well as the eligible business concern's name, point of contact, address, and DUNS number. Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking capability statements from all eligible Small Businesses as stated above. There is no solicitation available. This is strictly for market research. Background: 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. In support of NCI's clinical trials, the CTIMS contract has provided project management for the coordination of NCI research efforts. This includes efforts around clinical trials accrual, correlative science studies, precision medicine studies, and the early drug development process. It has supported the acquisition, review and analysis of data and information from NCI-sponsored extramural clinical research. In addition, this contract has provided administrative support for the coordination and oversight of CCCT scientific steering committee meetings, task force and working group meetings, concept evaluations, and other meetings and activities. 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). Purpose and Objective: 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. Project Requirements: The work is divided into four major Sections. Organizations will be required to: 1. Contract Transition (Phase-In and Phase-Out) In the event there is a new awardee other than the incumbent, the Contractor shall implement a seamless transition and maintain ongoing work during the entire Phase-In process occurring within the first 45 days of contract award. In the event a Phase-Out process is required, the Contractor shall ensure an orderly, secure, efficient, and expedient transition of all contract activities by the expiration date of the contract to the successor contractor, which shall encompass forty-five (45) calendar days. 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 Information Specialists, 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 Project Management The Contractor shall provide clinical trials project management support across five-sub-task areas. These contract staff, referred to as Clinical Trials Project Managers (PMs), shall work collaboratively with NCI Professional Staff to: Coordinate, Track and Support Accrual to CTEP-Sponsored Trials from Activation to Completion Provide Project Management Support and Coordination to DCTD Correlative Science Studies (CSS), CCCT Scientific Steering Committees, and CTAC Provide Project Management to NCI Precision Medicine Trials Provide Project Management support to NCI's Early-Phase Development Projects Provide Project Management support to NCI Cancer Moonshot Networks and Projects 4. CCCT Scientific, Administrative and Logistical Meeting Support The Contractor shall provide scientific, administrative, and logistical support for CCCT is broken into four task areas: Scientific Steering Committee and Task Force Support Clinical Trials and Translational Research Advisory Committee (CTAC) and CTAC Subcommittee Support Working Group (Ad-hoc) Support Additional Administrative Support for Scientific Steering Committee and CTAC Related Activities as needed. Anticipated Period of Performance: It is anticipated that one (1) cost reimbursement contract will be awarded with one (1) year base plus six (6) one (1) year option periods beginning on or about June 1, 2021. Other Important Information: Capability statements must clearly demonstrate past performance and expertise in the (1) Quality of Personnel and Experience; (2) Technical Approach and Understanding of the Project; (3) Corporate Experience and Management and (4) Facilities and Equipment. Capability Statement/Information Sought: We encourage small businesses to submit a capability statement which will be considered by the agency. Small businesses possessing experience and demonstrated capability to accomplish the requirements should supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Organizations that submit capability statements in response to this notice shall clearly document and demonstrate capabilities in their technical approach, personnel, corporate experience and management, and facilities and equipment. Capability Statements submitted in response to this notice are not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc.) presented in a single -space format using 12-point font size minimum. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Responses must reference the sources sought number and include the following: 1. Current certified business status 2. Name and Address of the Company, DUNS number. 2. Point of contact with name, title, address, phone, fax and email. 3. Examples of prior completed Government contracts, references, the dollar value of that work, and other related information; 4. List of organizations to whom similar types of services have been previously provided and the dollar value of that work. Submission Information: Please respond by e-mail with a capability statement to Mesfin Alemayehu at mesfin.alemayehu@nih.gov and Jame Chang at jame.chang@nih.gov by 2:30 PM EST on March 11, 2020. All capability Statements must be in MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. No collect calls or facsimile transmissions will be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.