Case Study: Closing the Gap Before It Became a Finding

Client: A US-based sponsor running a phase 2 oncology trial, with a critical imaging vendor supporting the primary endpoint.

The situation

The vendor had been qualified cleanly at study start, but oversight since then was calendar-driven, not risk-based. The sponsor's team had limited visibility into what was happening on the vendor's side and engaged VedX Clinical for an independent audit ahead of a regulatory inspection.

Key findings

• A reader-management change at the vendor had never been logged or assessed for impact on the endpoint
• Rising discordance and turnaround metrics had been filed but never reviewed or escalated
• No clear ownership of vendor-related decisions — history lived in emails and calls, not in a system

The outcome

VedX helped the sponsor close these gaps and build a defensible record well before the inspection. When it came, the team could answer every question on the vendor relationship with documentation, not recollection.

The takeaway

A clean audit at qualification is a snapshot. What holds up in an inspection is whether change gets noticed, assessed, and acted on — especially for critical vendors at a distance.

Want the detailed report on this case study for free? Request it at bd@vedxclinical.com.