Clinical Trials and Information Management Support
Added: Jul 17, 2015 11:31 am
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 541990 in 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 HHSN261201100010C awarded to the EMMES Corporation. 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 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 ManagementThe 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 CompletionB. Provide Project Management Support and Coordination to DCTD Correlative Science Studies (CSS)C. Provide Project Management to NCI Precision Medicine TrialsD. Provide Project Management support to NCI's Early Drug Development Project Teams (PT)IV. CCCT Scientific, Administrative and Logistical Meeting SupportScientific, administrative, and logistical support for CCCT is broken into four task areas: A. Scientific Steering Committee SupportB. Task Force SupportC. Working Group (Ad-hoc) SupportD. Additional Administrative Support for Related ActivitiesV. OptionsA. Increased CapacityB. Phase-Out TransitionAnticipated Period of Performance:It is anticipated that one (1) cost reimbursement contract will be awarded with one (1) year base plus four (4) one (1) year option periods beginning on or about May 01, 2016.Other Important Information:The offeror must be able to demonstrate past performance and expertise in (1) Personnel, (2) Technical Approach, (3) Organizational Experience and (4) Facilities and Equipment.Capability Statement/Information Sought:To be deemed capable of providing services that meet the CTEP's requirements, please submit a written capability statement demonstrating your ability and experience.Submission Information:Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Statements should also include an indication of current certified small 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 small business concerns name, point of contact, address and DUNS number. Responses will be reviewed only by NIH personnel and will be held in a confidential manner.All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Rukshani Levy, at Rukshani.Levy@nih.gov in MS Word or Adobe Portable Document Format (PDF) by July 31, 2015 3:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT 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.
N02CM61000-44 Department of Health and Human Services National Institutes of Health
7/17/15, 11:31 AM 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 ManagementThe 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 CompletionB. Provide Project Management Support and Coordination to DCTD Correlative Science Studies (CSS)C. Provide Project Management to NCI Precision Medicine TrialsD. Provide Project Management support to NCI's Early Drug Development Project Teams (PT)IV. CCCT Scientific, Administrative and Logistical Meeting SupportScientific, administrative, and logistical support for CCCT is broken into four task areas: A. Scientific Steering Committee SupportB. Task Force SupportC. Working Group (Ad-hoc) SupportD. Additional Administrative Support for Related ActivitiesV. OptionsA. Increased CapacityB. Phase-Out TransitionThe 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 DriveBethesda, Maryland 20852Primary Point of Contact: Charlotte McCormackContracting OfficerCharlotte.mccormack@nih.govPhone: 240-276-5409Secondary Point of Contact: Rukshani LevyContracting OfficerRukshani.levy@nih.govPhone: 240-276-5425
N02CM61000-44 Department of Health and Human Services National Institutes of Health
12/15/15, 3:24 PM