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Sphere on Spiral Stairs

CLINICAL START UP STUDY

Clinical study start-up is a complex and highly regulated part of a clinical trial involving several stakeholders (sponsor, site, regulatory authorities, etc.). Study start-up includes many milestones starting with feasibility and ending with the enrollment of the first subject, with several activities in-between such as site selection, pre-study visit, regulatory submissions, site contract and budget negotiation, vendor set-up, and site activation.

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