Study Start-Up (SSU) refers to the operational phase that prepares a clinical trial to enroll participants at a site.
SSU typically includes feasibility, contract and budget negotiation, regulatory submissions, document collection, training, system access setup, and site activation. Delays in SSU are a major driver of overall trial timeline risk, so many sponsors track SSU metrics closely. Standardized SSU processes improve speed while maintaining compliance and documentation quality. Efficient SSU supports faster first-patient-in milestones and more predictable execution across multi-site programs.