Hear a firsthand account of sponsor and site perspectives on managing and conducting a large, multicenter medical device trial involving a large network of satellite sites. Presenters will discuss the emergence of satellite sites in the current climate of hospital mergers with healthcare networks and/or clinics merging under a single healthcare entity. Leave with a clear understanding of what a satellite site is, the ability to evaluate whether a satellite site is suitable for clinical trial conduct, and the knowledge to apply this information to current practices.
Identify satellites sites - early detection is key but identification can occur at all stages of a clinical trial
Implement best practices: e.g. Early detection; Discussions at interest visits, site qualification visits and site initiation visits; Ongoing evaluation during study conduct; IRB oversight (Local and/or Centralized)
Apply appropriate study conduction: e.g. Subject enrollment and tracking; Subject follow ups and assessments; Investigational device management; Housing and maintenance of study documents; Study staff at satellite locations; Monitoring, PI oversight and Safety reporting management among other topics