Sites & Operations
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.
Site selection determines whether a trial enrolls on time. Industry data show that ~37% of selected sites under-enroll and 11% never enroll a single patient (Tufts CSDD), so the cost of a poor site selection decision is measured in months of delay and millions in burn rate.
Traditional site selection relies on relationship-based outreach plus feasibility questionnaires; this is slow (8; 12 weeks per study), self-reported, and biased toward known sites. Modern intelligent site selection combines structured data on >300,000 global sites; investigator publications, regulatory submissions, prior trial enrollment velocity, EHR-derived patient prevalence, and FDA inspection history; with multi-dimensional AI scoring against the protocol's specific criteria.
A defensible site selection package includes: (1) the scoring methodology, (2) the site shortlist with rank and rationale, (3) backup sites by region, (4) a diversity and equitable access analysis, and (5) a feasibility-confirmation plan.
Related terms
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.
Site Qualification Visit (SQV)
A Site Qualification Visit (SQV) is the on-site or remote evaluation conducted by a sponsor or CRO before site activation, to confirm that a candidate site has the personnel, facilities, processes, and patient access required to conduct the planned clinical trial in compliance with GCP.
Site Network (Clinical Trials)
A clinical trial site network is a curated, queryable database of clinical research sites with standardized profile data; including investigator credentials, therapeutic-area experience, prior trial performance, infrastructure, and regulatory standing; used to support site identification and selection.
Investigator Brochure (IB)
An Investigator's Brochure (IB) is the comprehensive document, updated at least annually, that summarizes all available clinical and non-clinical data on an investigational product, allowing investigators to assess the benefit-risk balance for trial participants.
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