RFI : CBRN Advance Defense Enabling Network and Clinical Capability ( CADENCC ) program

2026-11-03

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 andestablish 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 / ASSETS1 . 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 INITIATION1 . 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 studyexecution , 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 enrollmentENABLE DECENTRALIZED DATA COLLECTION USING DIGITAL HEALTH TECHNOLOGIES1 . 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 MCMs1 . 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 , vaccinesb . Devices / diagnosticsc . Varying administration routes including , but not limited to : oral , Subcutaneous , nasal , nebulized , intramuscular2 . 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 CAPABILITIESProvide 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 CAPABILITIESProvide information on your configuration management experience to include requirements management , data management , change management , records management , document control , library management . PROGRAM MANAGEMENT CAPABILITIESProvide 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 .

Maryland

2026-05-02