Clinical Trials Monitoring Service

Introduction This is a Non-Research and Development (Non-R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This requirement is assigned the NAICS code 541990, All other professional, scientific and technical services. Background This National Institutes of Health (NIH), National Cancer Institute (NCI), Cancer Therapy Evaluation Program (CTEP) project is for the work related to the contract below: Clinical Trials Monitoring Service (CTMS) under Contract Number HHSN261201700009C This contract was awarded on a competitive basis to Theradex Systems, Inc. effective May 1, 2017. The award was for a five-year period (inclusive of options) to provide data management, quality assurance, clinical trial monitoring and auditing capability, for NCI sponsored clinical trials at participating sites both within and outside of the U.S. and monitoring for current Good Manufacturing Practices (cGMP) for biopharmaceutical manufacturing facilities and Good Laboratory Practices for Core Laboratories performing investigational integral and integrated biomarker assays. This support services contractor works with the Experimental Therapeutics Clinical Trials Network (ETCTN), NCI Network Groups, NCI Community Oncology Research Program sites, international groups/institutions, other selected multi-institutional consortiums, and other NCI third party contractors. As such, Theradex Systems, Inc. is integrally involved in data management and quality assurance of early phase clinical trials and has access to PII under strict data security requirements. This contract was awarded as a cost-plus fixed fee, level of effort contract with an initial base period from May 1, 2017 to April 30, 2018. The contract included four (4) one-year option periods for a total potential period of performance through April 30, 2022. The total potential value of the contract, inclusive of options, is $36,037,179. This Source Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NCI. Purpose and Objectives The purpose of this Non-Research and Development Source Sought Notice is to discern whether or not there are other contractors, including small and small disadvantaged businesses, capable of and interested in performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this Non-R&D Source Sought Notice, the NCI may issue a Request for Proposal (RFP) if it deems this necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Source Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. The objective of this acquisition is to increase the quantity of labor hours delivered to the Government through the remainder of the current contract by increasing the effort to provide technical expertise and services to expand on the Web Reporting System and implement a process for making both clinical and biomarker data available in a controlled access database as additional support services for the fieldwork activities, support the NCI COVID-19 in Cancer Patients Study (NCCAPS) that will examine the effects of COVID-19 in patients currently undergoing or recently completed cancer treatment and support Moonshot Biobank related activities. In order to achieve this, additional labor hours will need to be added by increasing the existing level of effort under current contract HHSN261201700009C. Project Requirements COVID-19 Cancer Study On March 13, 2020, The President of the United States declared the COVID-19 outbreak a national public health emergency. In response, the NCI has launched an important study regarding COVID-19 in cancer. NCI COVID-19 in Cancer Patients Study (NCCAPS) is a natural history study that will examine the effects of COVID-19 in patients currently undergoing or recently completed cancer treatment. NCCAPS will be enrolling approximately 2,000 patients at over 1,000 sites affiliated with the Experimental Therapeutics Clinical Trials Network (ETCTN), NCI's National Clinical Trials Network (NCTN) and National Community Oncology Research Program (NCORP). Currently annual enrollment for Clinical Trials Monitoring Service monitored studies is approximately 1,200 patients and enrollment will double with the addition of the NCCAPS study during Option Period 4 (Year 5). An increased level of effort is required to extend these activities for Option Period 4 (Year 5) due to the increased work demands on the current contract. Integration of Biomarker Data with Clinical Data (Free the Data) As part of one of the NCI Director's initiatives for, - Improving the public availability of clinical and molecular data from NCI-supported treatment trials, this contract includes efforts to make early clinical trial data available to outside researchers in a controlled access environment. Additionally, it includes efforts to facilitate processes and mechanisms to enable the biomarker and molecular data to be integrated with the clinical data in the web reporting module with the goal of making this data available in the NCI clinical trials data archives (NCTN/ETCTN/NCORP Archive, GDC, CIDC, Navigator). The Contractor shall expand on the Web Reporting System and implement a process for making both clinical and biomarker data available in a controlled access database for outside investigators (researchers who are not part of the Study Team on a given protocol) to perform secondary analysis. The Contractor shall integrate with the current NCTN/NCORP/ETCTN Archive, Genomic Data Commons, Cancer Immune Monitoring and Analysis Center, and Navigator. Moonshot Biobank There's a need for the continuity of the activities being performed under this contract to support the Cancer Moonshot Biobank Project. The Moonshot Biobank will support research by establishing the infrastructure for longitudinal biospecimen collections from a diverse patient population engaged at multiple medical institutions in the U.S. For the Biobank project, all participating sites will function under a single IRB protocol and all sites will use a single Clinical Data Management System (CDMS). The clinical data system utilized will be built in the current Contractor's instance of Rave. The Contractor will be responsible for Data Management for the study and IT integrations for other systems involved in this project. Anticipated Period of Performance The increase of 11, 386 labor hours is anticipated to be applied to the Option Period 4 of the contract. The current estimated cost inclusive of fixed fee for the Option Period 4 is $4,941,082 and the negotiated level of effort is 34,305 hours. The period of performance for Option Period 4 is 5/1/2021-4/30/2022. The Contractor shall have a fully operational clinical data management system (eCRFs built in Medidata Rave), process for quality assurance review of submitted data, on-site/remote monitoring capability for participating sites, thorough knowledge of database structures to support the integration of clinical and biomarker data. Since the NCCAPS and Moonshot Biobank projects are on-going efforts with patient enrollments continuing, these studies must be fully supported without interruptions. Other Important Considerations Capability Statement Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors facilities, qualifications, and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to organizational experience in the following areas: 1. Experience with providing a centralized patient registry, building and revising as necessary studies using electronic case report forms utilizing Medidata Rave. 2. Experience in performing data management, quality assurance review of submitted data and issuance of queries 3. Experience in conducting monitoring visits of the NCI Sponsored clinical trial sites to ensure compliance with regulatory and protocol requirements and to ensure the integrity of data. 4. Experience in assuring adherence to the Clinical Trials Monitoring Branch (CTMB) monitoring guidelines. 5. Experience and expertise in integrating with the current NCTN/NCORP/ETCTN Archive, Genomic Data Commons, Cancer Immune Monitoring and Analysis Center, and Navigator. Sources are expected to have the necessary skills and tools to meet the requirements of this project. Capability statements must include the following: 1. Respondents DUNS number, organization name, address, and point of contact. 2. Small business type(s), if applicable. 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. All capability statements sent in response to this Sources Sought notice must be submitted electronically (via email) to DeChanta Vaughan, Contract Specialist, at dechanta.vaughan@nih.gov and Pooja Rathore, Contracting Officer, at pooja.rathore@nih.gov in MS Word or Adobe Portable Document Format (PDF) by Thursday, March 25, 2020 at 1:00 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. Collect calls or facsimile transmissions will not 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.