Case Study: Redesigning an Intra-EU Clinical Supply Flow in SAP
Clinical trial supply chains are unforgiving. The moment a process is unclear, undocumented, or too manual to execute reliably under pressure, the risk lands in one place: delayed IMP delivery to patients.
This case study describes a project in which Doctor K Consulting redesigned an existing intra-EU clinical supply flow for a client operating across multiple countries in a GxP-regulated SAP environment, replacing a cumbersome, manual-heavy process with a leaner, system-driven one.
The situation
The client's IMP moved across three EU countries: manufactured by a CMO in Country A, delivered to a labelling partner in Country B, then dispatched to a CRO in Country C. The existing SAP process met all regulatory and compliance requirements, but it was painful to operate.
Stakeholders across Supply Chain, Logistics, Finance, Controlling, Tax, Quality, and Clinical Trials all flagged the same concerns: too much manual work, poor visibility of product status across the chain, and a general lack of understanding of what other functions were doing and when.
The compliance box was ticked. The process was not working.
The approach
The project began with a structured cross-functional analysis, dissecting each process step, mapping the product's status at every stage, and identifying who held responsibility and custody of goods at each handoff. This produced a clear flowchart that all stakeholders could read and verify, regardless of their functional background.
Requirements were then gathered stream by stream:
— Supply Chain and Clinical: real-time product visibility to support planning
— Logistics: automatic generation of delivery documents, eliminating manual preparation
— Finance, Controlling, and Tax: correct accounting treatment and system-driven value reporting in each country, including tax implications
— Quality: appropriate goods inspection and quality release setup on each leg of the flow
— Intrastat reporting requirements for intra-EU goods movements
With requirements defined, each point was translated into SAP configuration covering organisational elements, document and output types, and user authorisation adjustments. All changes were documented throughout. Testing followed a structured approach: end-to-end technical testing with the IT team, followed by UAT with subject matter experts using an approved test script.
Once validated, the process went live.
The outcome
Following go-live, manual data preparation was eliminated for the key delivery steps. Delivery documents were generated automatically in SAP. Stakeholders across all streams reported significantly clearer process understanding, including a stronger grasp of steps outside their immediate area of expertise.
Most importantly: the redesigned flow reduced the risk of IMP delivery delays, freeing teams to focus on higher-value work rather than navigating a fragile manual process under time pressure.
The underlying principle
Regulatory compliance is the floor, not the ceiling. A process that meets every GxP checkpoint but is too complex to execute reliably is not a good process - it is a risk that hasn't materialised yet.
The goal of clinical supply chain design in SAP is a flow that is compliant, transparent, and operable by the people who have to run it every day.
