Site selection represents a pivotal decision point in clinical trial planning that significantly influences the ultimate success or failure of a study. This process transforms feasibility data into actionable selection decisions, balancing multiple criteria including patient access, investigator qualifications, site infrastructure, regulatory environment, and geographic diversity requirements. The goal is to identify a portfolio of sites collectively capable of enrolling the target population within projected timelines while maintaining quality and compliance.

The selection process evaluates sites across multiple dimensions. Scientific considerations include investigator expertise in the therapeutic area, familiarity with the disease population, and experience with similar trial designs. Operational factors encompass enrollment capacity, adequate staffing, appropriate facilities and equipment, and established regulatory documentation processes. Compliance history from previous trials, including inspection outcomes and audit findings, informs risk assessment. Geographic and demographic considerations ensure the enrolled population represents the intended patient population for the therapy.

Site selection visits provide essential verification of capabilities claimed during feasibility and enable assessment of factors difficult to evaluate remotely. During these visits, sponsor representatives meet with the investigator and study team, tour facilities, review regulatory files from previous studies, and assess the overall environment for trial conduct. The sponsor evaluates whether the site demonstrates genuine commitment to the trial and possesses the infrastructure necessary for success. Final selection decisions integrate all available information to identify sites offering the optimal combination of enrollment potential, quality track record, and operational capability.