Sites & Operations
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.
SQVs typically assess: investigator and coordinator experience, recruitment plan credibility, infrastructure (pharmacy, laboratory, imaging, biobank), regulatory standing and inspection history, and confidentiality / informed-consent processes. Findings drive the site selection decision and shape the activation plan.
AI-assisted site selection (Kitsa) reduces SQV load by pre-filtering sites against structured criteria and pre-populating the qualification packet from existing data, so SQVs focus on confirmation rather than discovery.
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.
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.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is the international ethical and scientific quality standard, codified in ICH E6, for designing, conducting, recording, and reporting clinical trials that involve human participants.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
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