When preparing a budget for a clinical trial you need to perform an internal cost analysis by evaluating your study specifications and determining expected enrollment. You need to determine how long the study will take?, Are you able to find a CRO will give you a reasonable cost for the study?. Also, it is important to account for hidden costs (like services/items not listed in the protocol), such as institutional review (IRB) review fees, advertising for recruitment, document archive and storage fees, close-out costs, inspections, and audits.