Clinical Trials Monitoring Service (CTMS)

Introduction 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; women-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 the NAICS code 541715, and the SBA size standard for such a requirement is 1,000 employees. This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). 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. The Capability Statements submitted in response to this notice should 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. Background The mission of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program for cancer research and by sponsoring clinical trials to evaluate new anticancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects. The purpose of this acquisition is to assist the NCI in fulfilling its responsibilities to the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations as an IND sponsor and funding agency. The Clinical Trials Monitoring Service (CTMS) contract is responsible for: Providing a centralized patient registry, protocol patient data capture system using Medidata Rave, and a quality control review process for early phase clinical trials including Phase 0, Phase 1, Phase 2 and randomized Phase 2 clinical trials conducted by NCI's Experimental Therapeutics Clinical Trials Network (ETCTN). Conducting monitoring visits of ETCTN sites to ensure compliance with regulatory and protocol requirements and to ensure the integrity of data. Assuring adherence to the Clinical Trials Monitoring Branch (CTMB) monitoring guidelines through Co-site visits with the NCI Network Groups, NCI Community Oncology Research Program sites and, and other selected multi-institutional consortium. Assuring that Cancer Centers, multi-institutions networks, or single institutions participating in clinical trials utilizing DCTD sponsored IND agents/funds are in compliance with Federal regulations, policies and procedures. Assuring through administrative and audit support that international groups/institutions collaborating with DCTD are in compliance with Good Clinical Practices (GCP) and the International Conference on Harmonization (ICH) standards. Serving as a resource for conducting audits of biopharmaceutical manufacturing facilities and Core Laboratories in accordance with GMP and GLP requirements, respectively. In 1979, CTEP initiated site visit auditing and monitoring of Phase 1 Clinical Trials when it established the Clinical Trials Monitoring Service (CTMS) contract. The first contractor for the CTMS contract was Besselar Associates; the contract included only Phase 1 data collection and audits. The CTMS contract was expanded in 1983 to include not only the Phase 1 data collection and the Phase 1 audit program but also the Cooperative Group co-site visits and the Cancer Center and single institution audits. Since 1983 Theradex Systems, Inc. has been the contractor. The services are currently being performed by Theradex Systems, Inc. under the contract number HHSN261201700009C titled - Clinical Trials Monitoring Service. Purpose and Objectives The scope of this contract is to: 1) Provide data management, quality assurance, clinical trial monitoring and auditing services for NCI sponsored clinical trials at participating sites both within and outside of the U.S., and 2) Provide monitoring for current Good Manufacturing Practices (cGMP) of manufacturing facilities and monitoring for Good Laboratory Practices of laboratories. The Contractor shall build, maintain, and enhance the operational infrastructure to support the tasks listed in the project requirements below. Project Requirements Independently, and not as an agent of the Government, the Contractor shall supply all the necessary services as needed to perform the work including licenses, labor, qualified personnel, materials, supplies, equipment, and facilities not provided by the Government. To assist the CTEP in fulfilling its regulatory responsibilities as an IND sponsor and to assure compliance with protocols, regulatory requirements and source data verification, the Contractor shall perform the activities including, but not limited to the following: Patient Registration and Protocol Data Capture, Data Management, and Quality Assurance Review Abstract approximately 40 new Phase 0, Phase 1, Phase 2 or Phase 1-2 protocols per year for studies that are conducted by the ETCTN, protocols that utilize CTEP-supplied IND agents, and other early phase CTEP approved protocols conducted by other CTEP supported Networks or institutions. Maintain and enhance the centralized, electronic patient registration system (Interactive Web-based Registration System (IWRS)) that is integrated with the Oncology Patient Enrollment Network (OPEN https://open.ctsu.org/open/home.open). Provide functionality unique to early phase studies (cohort management) while utilizing the NCI purchased Clinical Data Management System (CDMS) currently Medidata Rave, for building studies and data management. Provide data analysis tools accessible to NCI and key study staff. The contractor shall develop and implement a quality assurance process for ensuring the quality of submitted data. Develop and implement SOPs for the operation of a Data Safety Monitoring Board (DSMB) for the ETCTN for Phase 1/Randomized Phase 2 and Randomized Phase 2 studies. DSMB SOPs shall follow NCI Data and Safety Monitoring Guidelines as stated in: https://grants.nih.gov/policy/humansubjects/policies-and-regulations/data-safety.htm. 2. Monitoring of Phase 0, Phase 1 and Phase 2 Clinical Trials Conduct monitoring visits of approximately 100 sites participating in Phase 0, Phase 1 and Phase 2 studies. Provide a monitoring resource for the DCTD to assure that Contractors, grantees, and other clinical investigators conducting NCI sponsored clinical trials under the auspices of the ETCTN or other institution(s) or networks are in compliance with federal regulations, Good Clinical Practices (GCPs), and NCI and NIH policies and procedures. Conduct source data verification to assure the quality of the submitted data and perform pharmacy inspections. Sites accruing to Phase 1 studies identified as CTMS Comprehensive are to have monitoring visits conducted three times per year (if accrual is sufficient). Sites accruing to Phase 2 studies identified as CTMS Routine are to have monitoring visits conducted every 12-18 months based on accrual. More frequent and/or additional monitoring may be required if requested by the Contracting Officer's Representative (COR) for protocols deemed to be high risk. 3. Co-Site Visitation of NCI National Clinical Trial Network (NCTN) Groups, NCI Community Oncology Research Program (NCORP) and Division of Prevention (DCP) Research Bases and Selected Multi-Institutional Consortiums Attend approximately thirty (30) co-site visits annually or as otherwise assigned by the COR of audits conducted by the NCTN Groups, NCORP, DCP Research Bases or other multi-institutional consortiums/networks conducting NCI-sponsored clinical trials. The site visits will be conducted at institutions/sites throughout the U.S. and occasionally abroad. The site visits may include treatment, prevention, and advanced imaging trials or other trials as assigned by the COR. Assure the DCTD that the quality assurance programs of the NCTN Groups, NCI Community Oncology Research Program (NCORP), DCP Research Bases, and other selected multi-institution consortiums are actively monitoring their NCI sponsored clinical studies in compliance with NCI requirements. This shall be accomplished by having a CTMS representative attend audits that are organized and conducted by the NCTN Groups, DCP Research Bases or selected consortiums, as a co-site visitor. The COR shall assign which audits that a co-site visitor (CTMS representative) is to attend. 4. Auditing of Institutions/Investigators that do not have data management performed by CTMS Conduct approximately sixty (60) audits annually of Institutions/Investigators that do not have data management performed by CTMS, this includes approximately 40 audits to Pediatric Early Phase - Clinical Trials Network (PEP-CTN) sites. Conduct on-site or remote audits to ensure data integrity, protocol compliance, and source data verification every 12-36 months to assure the DCTD that all institutions outside of the ETCTN (including cancer centers, single institutions, multi-institutional consortiums and networks conducting clinical trials using NCI sponsored agents) are in compliance with the federal regulations, Good Clinical Practices (GCPs), and NCI and NIH policies and procedures. 5. Quality Assurance Program Support for International Group/Institution Collaborators Provide training sessions on an as needed basis, for monitoring of clinical trials in accordance with the NCI Guidelines for Auditing Clinical Trials for the NCI National Clinical Trials Network (NCTN) Program Including NCI Community Oncology Research Program (NCORP) and NCORP Research Bases (see: https://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm) in designated sites in Europe, Australia, South America or other foreign countries to assure that foreign collaborators are monitored and audited in the same standardized manner as U.S. Network Cooperative Groups or other NCI sponsored clinical trials network. Provide minimum administrative support to select international groups or institutions. 6. Perform on-site audits at Biopharmaceutical Manufacturing Facilities to ensure Compliance with Current Good Manufacturing Practices (cGMPs) Provide experienced auditor(s) to evaluate the compliance with cGMP standards (21 CFR Part 210 and 21 CFR Part 211) for facility design, utilities, equipment, personnel, training, adherence to Standard Operating Procedures, pharmaceutical quality/manufacturing standards, and product workflows as appropriate for early-phase product development. Ensure that there is no conflict of interest with the auditing facility and the individual(s) selected as auditor(s) to perform this evaluation. The individual(s) considered for this task shall have documented experience and expertise in conducting cGMP inspections. 7. Perform Audits/Sponsor Monitoring at Core Laboratory Performing Integral and Integrated Bio-marker Assays to ensure Compliance with Good Laboratory Practices (GLPs) Perform audit(s)/Sponsor monitoring at Core Laboratories performing integral and integrated bio-marker assays as directed by the COR to evaluate compliance with Good Laboratory Practices (GLP) and FDA requirements for use of biomarker assays under an Investigational Device Exemption. Provide experienced auditor(s) to evaluate the compliance with of GLP standards (21 CFR Part 58) and IDE regulations required for investigational integral assays biomarker assays utilized for treatment assignment and/or clinical decision making (21 CFR 812). Ensure that there is no conflict of interest with the trial facility and the individual(s) selected as auditor(s) to perform this evaluation. The individual(s) considered for this task shall have documented experience and expertise in conducting audits of laboratories performing bio-marker assays in accordance with Good Laboratory Practices and FDA Investigational Device Exemption regulations and requirements. Anticipated Period of Performance It is anticipated that one cost reimbursement term (level-of-effort) contract will be awarded with a one (1) base year plus nine (9) option years for a total of ten (10) years, beginning on or about May 1, 2022. Since the Government anticipates awarding a cost reimbursement term type contract for this requirement, in accordance with the requirements of FAR 16.301-3, the awardee will need to have an adequate accounting system prior to the award. It is also anticipated that the resultant contract may include options for Increased Capacity, Phase-In and Phase-Out Transitions. Capability Statement/Information Sought The Government encourages interested, qualified small business organizations to submit a tailored capability statement for this requirement which will be considered by the agency. Tailored Capability Statements submitted in response to this notice should supply pertinent information in sufficient detail to demonstrate the offeror's ability to perform the required services. Capability Statements should clearly convey information regarding the offeror's capabilities, including: (a) staff expertise, experience, and formal and other training; (b) awareness of project's needs and ability to perform the tasks; (c) organizational experience and management capabilities; (d) Facilities and Equipment available to perform the required services; and (e) examples of similar, prior completed Government contracts.. The capability statement shall not exceed 20 single-sided pages (including all attachments, charts, etc.), must be presented in single-spaced formatting and using minimum 12-point font size, and shall clearly detail the ability to perform the aspects of the notice described above. Capability statements must include the following: Company's DUNS number Company Name and Address Primary Business Point of Contact Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/. Please indicate if your organization will need to utilize the expertise and resources of subcontractors and specialized consultants to perform the full spectrum of requested activities. The Capability Statements must be submitted no later than January 22, 2021, 4:00 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. The capability statements shall be submitted electronically (via e-mail) to DeChanta Vaughan, Contract Specialist, at dechanta.vaughan@nih.gov and Pooja Rathore, Contracting Officer, at pooja.rathore@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF). The e-mail subject line must specify the notice number: HHS-NIH-NCI-SBSS-ETSB-75N91021R00014-16. Facsimile responses 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 beta.sam.gov. 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.