More case studies
Challange
A blue-chip sponsor launched a global respiratory study spanning 22 countries across the EU, North America, and South America. The protocol covered 80 sites and required sourcing 3–4 different products in each country, each with local presentation and strength differences. The study was planned for three years, but many products carried two-year shelf lives, forcing multiple purchasing cycles to avoid expiries. CSI had to stand up 22 local depots quickly to meet first-patient SIV timelines. Compounding the complexity, the sponsor frequently revised quantities, added/removed countries, and adjusted the protocol, all on tight timelines that left little room for error.
Solution
CSI implemented an adaptive, end-to-end supply strategy designed for scale and frequent change:
Rapid depot enablement: Activated and qualified 22 local depots with standardized SOPs, QA checks, and data flows to meet SIV dates.
Phased purchasing plan: Split procurement into three phases to keep inventory within shelf-life while ensuring continuous availability through the 3-year duration.
Market-by-market sourcing: Mapped country-specific presentations and strengths, validated what was marketed locally, and aligned label/pack formats to study needs.
Change resilience: Built flexible ordering windows and rolling forecasts to absorb last-minute sponsor revisions to patient counts, site numbers, and country mix.
Cold-chain & logistics control: Maintained temperature-controlled lanes where required, with monitored hand-offs from manufacturer through depot to site.
Regulatory & documentation readiness: Coordinated import/export paperwork, release documentation, and audit-ready records for each market.
Governance & visibility: Established a cadence with the sponsor/CRO, providing shipment trackers, exception logs, and inventory status by country/site.
Cost discipline: Optimized order sizes, shipment consolidation, and replenishment timing to keep the program within budget despite scope shifts.
Result
CSI completed the complex, multi-country supply successfully and within budget. Sites received the required products and strengths on schedule, inventory remained within shelf-life through the full duration, and the team absorbed frequent scope changes without interrupting recruitment or dosing. The adaptive plan, phased buying, and local-market expertise turned a high-variance, multi-year program into a stable, well-governed supply chain.
Case Study
CSI’s Expert Delivery of a Global Respiratory Study
Adaptive, multi-product supply across 22 countries and 80 sites, kept on time, in budget and compliant.
Challange
Global study across 22 countries and 80 sites needed 3–4 products per country, with varied presentations/strengths and a 3-year timeline vs. 2-year shelf-lives.
Solution
CSI set up 22 local depots fast, split purchasing into phases, and adapted to frequent sponsor revisions while maintaining cold-chain, documentation, and oversight.
Result
Study supply completed successfully and within budget—no interruptions despite scope changes and complex regional requirements.
Get in touch with a member of our experienced team today to discuss your clinical trial supply requirements
Contact us
.png){kind=logo}