Patient-level costs
Investigator grants, procedures, pharmacy, imaging, labs, travel, reimbursements and screen failures often scale with patient volume.
Site-level costs
Startup, contracts, ethics submissions, training, monitoring, closeout and recurring administrative fees scale with the number and complexity of sites.
Program-level costs
CRO project management, data management, statistics, pharmacovigilance, medical monitoring, regulatory work, central vendors, insurance, logistics and amendments can dominate even when patient grants look reasonable.
Questions people actually ask
FAQ
What is the biggest cost driver?
It depends on the protocol. Recruitment, patient procedures, site count, CRO scope or central vendors can each dominate.
Why do budgets change after startup?
Because amendments, slower recruitment, site replacement, extra monitoring and vendor changes can create unplanned cost.
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