Sites & Operations
Clinical Trial Startup
Clinical trial startup is the set of activities between protocol finalization and first-patient-in (FPI), including regulatory submissions, IRB/IEC approvals, contract and budget execution, site selection and qualification, central lab and IRT setup, IP labeling, and site initiation visits.
Startup is the most time-compressible phase of a trial; industry medians range from 6; 9 months for global Phase 3 studies, with site-by-site activation often the rate-limiting step. Tufts CSDD data show that startup represents 30; 40% of the total trial timeline.
AI-enabled startup reduces timelines through parallelized site identification, template-driven essential document collection, automated budget benchmarking, and predictive analytics on contract negotiation cycles.
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.
Site Initiation Visit (SIV)
A Site Initiation Visit (SIV) is the formal sponsor-led training and activation visit conducted at each clinical trial site immediately before the site is authorized to begin enrolling participants, typically following IRB approval and contract execution.
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.
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
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