Sites & Operations
Feasibility Assessment
A feasibility assessment is a structured evaluation of whether a planned clinical trial can recruit enough eligible patients, at qualified sites, within the required timeline and budget, given a specific protocol design.
Feasibility assessments operate at two levels. Country/regional feasibility evaluates regulatory pathway, standard-of-care alignment, competitive trials, and patient prevalence. Site-level feasibility evaluates each candidate site's patient flow, investigator interest, infrastructure (e.g., imaging, biobank), and competing studies.
A rigorous feasibility output produces an enrollment forecast with confidence intervals, an identification of protocol design choices that constrain recruitment (over-restrictive criteria, infeasible visit schedules, rare biomarkers), and a recommended modification list ranked by enrollment lift.
Modern AI-driven feasibility uses real-world data; claims, EHR cohorts, registry data; to ground prevalence estimates in evidence rather than coordinator opinion, then runs simulations across protocol-design alternatives to quantify the recruitment impact of each criterion.
Related terms
Site Selection (Clinical Trials)
Site selection is the process by which sponsors and CROs identify, evaluate, and choose the clinical trial sites best suited to enroll a given study, based on patient population access, investigator experience, operational capacity, regulatory standing, and historical performance.
Real-World Data (RWD) and Real-World Evidence (RWE)
Real-world data (RWD) is healthcare data collected outside the context of a controlled clinical trial; real-world evidence (RWE) is the clinical evidence about an intervention derived from analyzing RWD.
Inclusion / Exclusion Criteria
Inclusion and exclusion criteria are the protocol-defined conditions a person must satisfy (inclusion) or not exhibit (exclusion) to be eligible to enroll in a clinical trial.
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