Static, one-size-fits-all clinical supply chains create waste, delay trial milestones and heighten compliance risk, pressures now intensified by the EU Clinical Trials Regulation. In response, biotechs are shifting from large safety stocks to flexible, data-driven, patient-centric models that pair real-time enrollment forecasting with agile labeling and regional depots. “The most critical KPI in a clinical trial is ensuring patients receive 100% of their prescribed dose,” says Luke Wilson, senior director of clinical trials at Thermo Fisher Scientific, who outlines how just-in-time (JIT) labeling, regional depots and direct-to-patient delivery improve adherence and can cut drug overage from 20% to 10% in one case, saving about $8 million. In the Q&A that follows, Wilson details the KPIs that matter and practical steps to modernize clinical supply.
What do “smarter” clinical supply models look like and can you quantify how smarter models may cut delay days and waste, with examples?
Wilson: Smarter supply models should be flexible and data-driven, using real-time enrollment forecasts, regional depots, and adaptive labelling rather than large, static safety stocks. When executed correctly, savings may be significant and companies may reduce waste in the supply chain.
When executing smart supply chain models, close collaboration with the sponsor, CDMO and CRO teams is essential to enable tangible outcomes. The model should keep the patient at its center, while also pursuing opportunities to optimize Investigational Medicinal Product (IMP) use, reduce waste, and generate cost savings.
How are more agile supply models, like on-demand labelling or regional depots, helping sponsors navigate specific regulatory hurdles like EU Clinical Trials Regulation (CTR)?
Wilson: Under the EU Clinical Trials Regulation (CTR), retest dates must appear on outer packs for all drugs used in EU-based studies. Failing to update labels promptly can lead to delays, supply risks or noncompliance. Biotechs should turn to agile models to help reduce this risk by enabling on-demand labelling, often known as just-in-time (JIT), in Good Manufacturing Practice (GMP) facilities and regional depot relabelling with a Qualified Person (QP) release. What once required weeks for rework can now be completed quickly on demand.
At Thermo Fisher Scientific, customers will often approach us with requirements for JIT labelling as it enables flexibility to adapt packaging and labelling for different countries in multi-country clinical studies. JIT labelling is especially valuable in situations where the time between preparing the treatment and administering to the patient is limited, or stability data is limited but the sponsor needs to get their clinical trial started.
For which types of clinical trials (e.g., rare disease, cell and gene therapy) have you seen Direct-to-Patient (DTP) provide the most significant benefit?
Wilson: Direct-to-Patient (DTP) supply models deliver medical supplies directly to patients’ homes, which reduces the need to travel for site visits and makes participating in a trial more convenient for patients, especially for pediatric and elderly populations. We’ve seen that DTP models improve patient retention rates and adherence, cutting missed doses and protocol deviations compared to onsite trials. For example, rare disease trials, where patients are geographically dispersed or have limited mobility, have seen great successes with DTP models.
We recently had a situation where a US-based biopharma company had a rare disease study with ~200 pediatric patients that had a challenging supply chain and a need for a DTP model. They faced challenges supplying a refrigerated liquid IMP, as air travel and luggage restrictions made the supply chain complicated. In this case, we were able to implement a Pharmacy-to-Patient model where we installed home refrigerators, shipped monthly cold-chain supplies, and coordinated deliveries with nurse visits (30m-1hr after the arrival time of the nurse at the patient’s home). This approach ensured uninterrupted supply, reduced burden on patients and caregivers, and streamlined operations under a single contract.
The challenge with DTP models is that they require rigorous custody and temperature controls to ensure safety and regulatory compliance throughout the supply chain. To address these challenges, sponsors should look for clinical supply partners who can help them minimize logistical challenges and enable continuous monitoring, notifications and communications to patients and clinical sites.
Could you share a few key performance indicators (KPIs) you use to measure the efficiency of a clinical supply chain?
Wilson: Typical KPIs include On-Time-In-Full (OTIF) delivery, shipments with temperature deviations, on-time receipt of the shipment, packaging and labelling cycle times, resupply lead times, and inventory utilization.
The most critical KPI in a clinical trial, however, is ensuring patients receive 100% of their prescribed dose. To support this, we use shared data platforms that give both sponsors and suppliers real-time visibility. This allows us to course-correct proactively rather than reacting after issues arise.
We also leverage forecasting and scenario planning tools, which optimize manufacturing, distribution, and expiry management. In one case, we reduced drug overage from 20% to 10%, saving a sponsor about $8M in manufacturing costs while avoiding any stock-outs. It is important that the teams review data frequently to enable such savings, this is further simplified if the sponsor uses single partners such as Thermo Fisher Scientific and our integrated CDMO/CRO offering.
Filed Under: clinical trials, Drug Discovery
