Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE)   5

Background
The Biomedical Advanced Research and Development Authority (BARDA) is soliciting proposals for Clinical Trial Planning and Execution (CTPE) services to support the Clinical Studies Network (CSN). The CSN aims to advance the development of medical countermeasures (MCMs) by efficiently enabling rigorous clinical trials to assess safety and efficacy of drugs, devices, and biological products.

Work Details
The contract involves planning and executing clinical trials for MCMs related to chemical, biological, radiological, nuclear threats, pandemic influenza, and emerging infectious diseases. Tasks include project management, study start-up, site training and support, site feasibility and selection, site monitoring and management, specimen and investigational product management, laboratory services, regulatory services including IND application and FDA submission, Institutional Review Board services, quality assurance, medical monitoring with DSMB involvement, protocol development, site selection and feasibility studies, safety monitoring/pharmacovigilance activities including identification of adverse events (AEs), serious adverse events (SAEs), study pausing/stopping rules. The contract also includes establishing a Biological Specimen and Investigational Product storage facility (BSIP) and a Statistical Data Coordinating Center (SDCC).

Period of Performance
The base period of performance is anticipated to be two years from the date of award with up to three one-year option periods. The total period of performance shall not exceed five years from the original date of award.

Place of Performance
The contract will be performed at various clinical research sites that have access to special populations such as elderly individuals, immuno-compromised patients, neurologically impaired individuals, children, and infants.