Three ways to trust a vendor… and the risk you accept with each
by: Paul DavidsonPublished on: 31/03/2026Most vendor oversight strategies look robust on paper, but far fewer stand up to scrutiny when you examine when key decisions are actually made. This article explores the three common ways organisations build trust in their vendors, from pre-qualification audits to early in-study oversight, and challenges the assumption that these are simply operational choices. Instead, each approach reflects a different level of risk acceptance, often shaped more by timing, pressure, and internal dynamics than by deliberate design. Drawing on patterns seen across preclinical, clinical, and CSV environments, the piece questions whether audits are truly informing decisions or merely responding to them, and invites readers to reconsider how and when confidence in a vendor is really established.
Different functions, same mistake: a decision gap across GLP, GCP, and CSV
by: Paul DavidsonPublished on: 31/03/2026Across preclinical, clinical, and CSV environments, the same pattern repeats: vendors are often chosen before the real decision is openly discussed, leaving audits to confirm rather than influence the outcome. This article explores how that decision gap shows up in different forms depending on where you sit, from mid-study audits in preclinical work to overlooked laboratory risk in clinical trials and late-stage vendor qualification in CSV. Rather than focusing on process failures, it reframes the issue as a gap in how and when decisions are made, and offers simple ways to recognise and shift this dynamic in practice. The aim is not to add complexity, but to help organisations regain control of the moment where risk is truly decided.
The “low-risk” vendor that carries your highest exposure
by: Paul DavidsonPublished on: 31/03/2026Most organisations classify certain vendors as “low risk” because they sit outside core trial activity or are unlikely to be inspected. Laboratories, PK providers, and early-stage research partners often fall into this category. But the data they generate still shapes key decisions about whether a compound progresses or stops, and may ultimately feed into clinical development. Having asked QA professionals for years about the risks in this space, there is one answer that is consistently overlooked. This article explores that gap, highlighting the sponsor’s ongoing responsibility for data integrity regardless of regulatory scope. It challenges the assumption that limited oversight is justified and examines the less visible risks, including missed opportunities where promising compounds are abandoned based on unreliable data. It also outlines how a more proportionate, risk-based approach to oversight can be applied in practice, helping organisations build confidence in the data that underpins some of their most important decisions.
Does a Mock Inspection Really Prove You’re Ready?
by: Paul DavidsonPublished on: 28/02/2026Mock inspections are standard practice in regulated clinical research. They create activity, generate findings, and offer reassurance. But do they truly test whether your organisation is inspection ready, or do they simply re-document weaknesses you already suspected? In this month’s lead article, Gill and I challenge a common assumption: that rehearsing an inspection equates to resilience. Drawing on current regulatory expectations under ICH E6(R3) and practical experience across clinical environments, she explores the difference between superficial compliance and system capability. The piece examines what inspectors actually notice in the first hours of an inspection, why scripted answers and over-functioning QA departments are warning signs, and how leadership behaviour often determines inspection outcomes more than documentation alone. If inspection readiness is meant to be a state, not a project, this article invites clinical leaders to ask a more demanding question: does your system withstand pressure, or does it simply perform well in rehearsal?
