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

The CBRN Advance Defense Enabling Network and Clinical Capability (CADENCC) program is a Medical Architecture Accelerator designed to rapidly develop, test, and evaluate Medical Countermeasures (MCMs) for preparedness, prevention, protection, response, and recovery from CBRN threats. The program seeks to strengthen a clinical site network to generate safety and potentially efficacy data that enables CBRN defense readiness. The CADENCC program 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. The program is seeking information on capabilities and experience in areas such as clinical trial network management, accelerated clinical trial initiation, decentralized data collection using digital health technologies, and quality assurance. Some key points to consider include: • Experience in managing clinical trial networks or large-scale multi-site trials for clinical trials up to phase 2 completion, compliant with FDA regulations. • Ability to perform multiple/concurrent clinical trials and establish or leverage existing clinical trial sites in the Continental United States (CONUS) and Outside the Continental United States (OCONUS). • Accessing and/or developing a clinical trial network or consortium, including a description of the proposed model for the clinical trial network. • Innovative approaches and strategies to accelerate study start-up, execution, and close-out of clinical studies. • Experience in conducting clinical trials on varying product modalities, including biologics, small molecules, vaccines, devices, and diagnostics. • Quality assurance capabilities, including Good Clinical Practice (GCP) Compliance, Risk-Based Monitoring (RBM) practices, and Standard Operating Procedures (SOPs).