Find What's Slowing Your Supply Chain Down. Fix It. Get to Market Faster.
The GBS GAP Analysis: an end-to-end, candid, benchmark-backed assessment of your clinical supply chain, with a mitigation plan your team can actually execute.
You've said it yourself: "We're doubling our studies and I honestly don't know if the supply chain can take it." "We're moving from clinical to commercial and the gaps are multiplying." "Our SOPs are missing, outdated, or unreadable - and an inspection is coming." "Our ERP was built for commercial production. It takes new people a year to learn, and it still doesn't fit clinical."
If any of those sound familiar, you don't have a people problem. You have a process problem - and processes can be fixed.
What a GBS Gap Analysis Is
Over a focused engagement - typically 4-5 months for a full clinical supply chain - we map your supply chain end to end: every process, hand-off, system, and SOP, from protocol to returns and reconciliation. We benchmark you candidly against the industry, in real time and confidentially. We pinpoint the gaps with FMEA-based risk analysis. And we deliver a prioritized, practical mitigation plan: process maps, picture-based SOPs, timelines, and where useful, a supply chain control tower. Then we stay as long as you want us - implementation, training, or both.
What We Look At
Planning & forecasting, IRT/ERP systems fit, labeling & packaging flow, comparator sourcing, vendor & CMO management, temperature-controlled distribution & GDP, quality & technical agreements (QTAs), CAPA, TMF/DMF completeness, inspection & PAI readiness, returns, reconciliation & destruction, clinical-to-commercial transition, and org design & training needs.
Who It's For
Sponsor-side clinical supply, CMC, and clinical development leaders - Associate Director to VP - from emerging biotech to top-10 pharma, and the vendors and CMOs who serve them. Especially: teams about to scale, teams transitioning from clinical to commercial, and startups building their first SOP backbone before Phase 3.
When a top-10 global pharma decided to double its yearly clinical trials, they asked us one question: can our supply chain take it? In four months we mapped every system and hand-off (RACI included), issued 27 vendor RFIs, conducted 32 confidential voice-of-customer interviews across the industry, identified 94 risks with mitigation strategies for each, and delivered three complete sourcing models — including the control tower design they've since moved toward. That's what a GBS gap analysis looks like.
Common questions: How long does it take? Typically 4-5 months for a full clinical supply chain. Do you work under NDA? Always - confidentiality is standard. Do you do vendor-side gap analyses? Yes, for CMOs and packaging providers too. What do we get at the end? A prioritized, practical mitigation plan your team can execute - with as much or as little of our help as you want.
Your supply chain has a story like this waiting to happen. Book a Gap Analysis Consult with Steve.