The site selection visit (SSV) is the first step before an investigator site is activated. Its purpose: confirm that a candidate site genuinely has the means — people, facilities and organisation — to run your study in line with the protocol and Good Clinical Practice (ICH E6).
What the visit assesses
- The experience, availability and motivation of the investigator and the team
- A realistic — not theoretical — accessible patient pool and recruitment potential
- The facilities and equipment the protocol requires: pharmacy, storage conditions, technical platforms, data backup
- Quality processes, investigational product handling and traceability
- The site's capacity to absorb the workload and meet deadlines and regulatory obligations
Why it sets up everything that follows
A poorly chosen site is expensive: recruitment that never starts, repeated deviations, sometimes early closure. A clear-eyed selection avoids opening a site that cannot deliver — often the most profitable decision of the whole start-up.
How I work
I assess each site against objective criteria, then deliver a clear report with a reasoned recommendation (go, no-go, or conditions to clear). I flag the risks to address before initiation, so you get a reliable basis for decisions rather than a box-ticking exercise.
Need to assess one or more sites before committing to your study? Let's talk about your project.
Reference: ICH E6 (Good Clinical Practice).