Description
THIS IS A REQUEST FOR INFORMATION (RFI) ONLY – This RFI is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Solicitations are not available at this time. Requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government (USG) to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. It is the responsibility of the potential offerors to monitor Sam.gov for additional information pertaining to this requirement. Within the Department of War (DoW), the CPE-CBRND-ET develops, manufactures and delivers safe and effective Medical Countermeasures (MCMs) for preparedness, prevention, protection, response, and recovery from CBRN threats. Today’s chemical and biological threat landscape is diverse, dynamic, and regionally distinct. Agile and flexible defense systems are required to provide Combatant Commands (CCMDs) and other stakeholders throughout the Chemical and Biological Defense Program (CBDP) with safe and effective MCMs at the speed of relevance, especially if those MCMs are early in development. The CBRN Advance Defense Enabling Network and Clinical Capability (CADENCC) program is a Medical Architecture Accelerator designed to rapidly develop, test, and evaluate MCMs. Specifically, CADENCC seeks to strengthen a clinical site network to generate safety and potentially efficacy data that enables CBRN defense readiness. For example, CADENCC could streamline the execution of advanced development activities by establishing disease-agnostic Master Protocols (e.g., for “respiratory illness”) or sub-protocols (e.g., initial screening protocols), providing access to clinical trial networks, and integrating novel technologies. The network should be prepared to handle studies involving healthy volunteers and patient populations, potentially under demanding and rapid response timelines. CADENCC will likely identify an “Integrator” to serve as a central coordinating entity to perform necessary actions or subcontract as needed to performers to achieve Government-directed objectives. In this approach, the Integrator would identify and establish subcontracts with appropriate performers to complete typical activities associated with supporting a clinical trial network, as well as address or subcontract additional services to support unexpected requirements with appropriate advance notice. CPE-CBRND-ET has identified objectives listed below to enhance the CADENCC program's core assets. CADENCC is seeking information on capabilities and experience in the following areas (but not limited to). STRENGTHEN AND EXPAND CLINICAL SITE NETWORK INCLUDING WIDER GEOGRAPHIC COVERAGE AND LEVERAGE EXISTING PRE-POSITIONED CLINICAL SITES/ASSETS 1. Experience in managing clinical trial networks or large-scale multi-site trials for clinical trials up to phase 2 completion, compliant with Food and Drug Administration (FDA) regulations. 2. Ability to perform multiple/concurrent clinical trials. Include estimated time typically required to initiate a clinical trial and how those time projections may be impacted if multiple concurrent trials are running. 3. Establishing or leveraging existing clinical trial sites in the Continental United States (CONUS) (priority) and Outside the Continental United States (OCONUS) (option). 4. Accessing and/or developing a clinical trial network or consortium, including a description of the proposed model for the clinical trial network. Detail the governance structure, administrative oversight, and how a geographically diverse collection of sites would be managed. 5. Summarize coordination capabilities across a diverse group of sites which may include federal, state, public health, military, academic and private facilities. FACILITATION OF ACCELERATED CLINICAL TRIAL INITIATION 1. Detail the network’s collective experience with both Phase 1 and Phase 2 clinical trials. Specify experience in clinical trials such as first-in-human studies, SAD/MAD, dose-ranging, and preliminary efficacy studies. 2. Discuss innovative approaches and strategies that would be employed to accelerate study start-up, execution, and close-out of clinical studies to significantly compress the traditional trial timeline, while still satisfying safety and rigor requirements of regulatory authorities. Include the following: a. Standardized Informed Consent Forms (ICFs) or other techniques. b. Screening protocols and/or streamlined participant identification and recruitment techniques and engagement. For example, identify methods to pre-position subjects by soliciting interest/ engagement in advance of study execution, and identify corresponding level of agency(s) approval necessary to engage methods and any potential schedule reduction. c. Standardized or existing regulatory processes and experience including early involvement with regulatory bodies and review boards in both CONUS and OCONUS settings; for example, Institutional Review Boards (IRBs), Ethics Committees (ECs), US Army Medical Research and Development Command Office of Human Research Oversight (OHRO), and others. d. Experience in streamlining communication with FDA to facilitate protocol review, INDs, etc. e. Experience in collaborating with government agencies such as the FDA and the DoW in the planning and execution of clinical trials. 3. Approaches to, and experience in, the development of master protocols, including adaptive platform trials, umbrella trial protocols, basket trial protocols, or other protocols capable of evaluating multiple products. a. Experience in approaches such as built-in down-select, interim analysis, and clinical objective/endpoint shifts. b. Experience or ability to use master protocols to conduct phase 1, phase 2 and pharmacokinetic studies. 4. Summarize strategies to identify, enroll and maintain subjects such as expediting subject enrollment and/or mitigating slow enrollment ENABLE DECENTRALIZED DATA COLLECTION USING DIGITAL HEALTH TECHNOLOGIES 1. Provide information on leveraging AI, technologies (including health technologies) and innovation to clinical trials, including recruitment/achieving enrollment targets, data collection, data quality and assurance, and more. 2. Provide information on developing a remote/decentralized approach to conducting clinical trials, including data collection, safety data, and participant monitoring. ACCELERATE CLINICAL EVALUATION OF MCMs 1. Provide information on abilities to conduct clinical trials on varying product modalities including level of participant support (inpatient vs. outpatient vs. human challenge) (for example, but not limited to): a. Biologics (including antibodies), small molecules, vaccines b. Devices/diagnostics c. Varying administration routes including, but not limited to: oral, Subcutaneous, nasal, nebulized, intramuscular 2. Discuss innovative approaches and strategies that would be employed to accelerate study start-up, execution, and close-out of clinical studies to significantly compress the traditional trial timeline, while still satisfying safety and rigor requirements of regulatory authorities. QUALITY ASSURANCE CAPABILITIES Provide information on Good Clinical Practice (GCP) Compliance according to the International Council for Harmonisation (ICH) GCP E6(R3) guidelines: Ensuring adherence to international ethical and scientific quality standards for designing, conducting, and reporting trials. Provide information on Risk-Based Monitoring (RBM) practices that are utilized. RBM is a data-driven approach focusing on critical trial processes to prevent, identify, and correct errors in real-time, moving away from 100% on-site source data verification. Provide information on Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity in performance, which are essential for maintaining quality. Describe practices to ensure data management and integrity: Procedures to ensure data is accurate, complete, and verifiable, including data validation checks and secure, traceable data handling. Provide information on your Quality Management System (QMS). State whether the QMS is equivalent to ISO 9001:2015 standard and if it is aligned with MIL-STD-1916 where appropriate. Provide information on quality assurance practices. Examples include change control processes describing modifications to facilities, equipment, or procedures; documentation and investigation practices for deviation management; calibration and preventative maintenance programs; and audit trail documentation of activities. Describe how data integrity is maintained such as secure data storage and retrieval systems and mechanisms to ensure data accuracy, completeness and traceability. Provide information on auditing and inspections: Independent reviews of trial-related activities and documentation to confirm accuracy and compliance, often conducted by internal Quality Assurance (QA) departments or third parties. CONFIGURATION MANAGEMENT CAPABILITIES Provide information on your configuration management experience to include requirements management, data management, change management, records management, document control, library management. PROGRAM MANAGEMENT CAPABILITIES Provide information on your Program Management experience to include technical and administrative support, standard operating procedures, supply chain management, and risk management. The response date for this market research is 25 March, 2026. Page limit for response is 10 pages. All responses to this RFI may be submitted via e-mail to the POCs listed below.