The Key Role Of Clinical Supply Teams In Patient Centricity Efforts

By Tom Wells, director, Life Sciences, 4C Associates

Every activity in clinical research is supposed to serve one purpose: improving patient outcomes. Yet in many organizations, clinical supply can slip away from that purpose. Conversations start with budgets, timelines, contracts, and compliance artifacts – and the patient often only enters the discussion once decisions are already shaped.

When supply functions struggle, the consequences are immediate for patients: anxiety when a delivery doesn’t arrive, treatment interruptions, and the creeping sense that the system is less reliable than they were told. Sponsors and society pay the price through slower trials and delayed therapies that could have helped sooner.

Procurement, supply chain, and sustainability cannot sit on the sidelines. They shape patient experience and patient access, whether we acknowledge it or not.

Drug Development Has Changed And Clinical Supply Must Keep Up

Therapies have grown far more complex, and cell and gene therapies, biologics, and targeted treatments dominate many pipelines. These products demand precise handling, dependable temperature control, and strong chain-of-custody processes. Many have short shelf lives; some are produced for individual patients. Slack simply does not exist.

Patient populations are getting smaller and harder to reach, particularly in rare disease studies. A single missed participant can derail statistical integrity and knock a program off-course. Even in large Phase 3 trials, a single missed dose is still a human setback, not just a line on a report.

Trials are also more geographically dispersed and operationally complex. Decentralized and hybrid models expand access, but they introduce new layers of complexity: multiple delivery routes, blurred lines of accountability, and inconsistent interpretation of regulatory expectations.

And all of this unfolds amid geopolitical, sourcing, sustainability, and regulatory pressures. Even experienced supply teams can find themselves relying on assumptions that no longer hold.

Patient Outcomes Are Shaped By Supply Decisions

Patient centricity in clinical supply isn’t about slogans – it shows up in the day‑to‑day decisions that determine what patients experience.

• Access dictates whether a patient can join a trial at all; if a product can’t reach their clinic, community, or home, the trial effectively excludes them.
• Equity depends on how supply is designed: centralized models often favor major urban sites; without deliberate planning, underrepresented groups stay underrepresented.
• Continuity relies on reliability: a missed shipment for us is a missed treatment for them.
• Safety is fundamental: temperature excursions, mislabelling, and weak accountability put patients and data at risk.
• Speed matters: slow starts delay recruitment and push therapies further into the future.
• Affordability shapes the universe of options: escalating supply costs force sponsors to cut scopes, reduce sites, or cancel programs, directly affecting patient access.

These aren’t theoretical ideas – they’re the consequences of supply-chain design, procurement strategy, and sustainability choices. A couple of real-world scenarios illustrate the point:

• A decentralized oncology trial: Courier pickups close at 4 p.m.; pharmacies often release product at 4:30. That 30‑minute mismatch leads to overnight holds. Patients get cancelled visits; sites redo work; retention weakens.
• A gene therapy with a 72‑hour shelf life: One congested international hub delays a delivery by half a day. The product falls outside its window; the patient’s schedule is pushed back; the site scrambles to reorganize and loses capacity for the rest of the week.

Where Clinical Supply Helps - And Where It Gets In The Way

1. Patient-centric delivery models: promising, but not yet consistent

Decentralized trial components and direct-to-patient delivery promise convenience and broader reach. For many patients, they can be transformative. But the execution varies dramatically: regulatory expectations differ across regions; roles for storage and accountability aren’t always clear; procurement approaches sometimes split responsibilities across multiple vendors, creating more handovers and more points of failure. I believe that patient-centric delivery works best when it’s built-in to a single continuous process, not bolted on to an outdated site‑centric model.

2. Advanced therapies and cold chain: precision, with a price

Cold chain capabilities have improved significantly, protecting both patients and data, but the trade-offs are real. Cold chain infrastructure is expensive, packaging volumes rise, distribution routes narrow, and serving remote patients becomes more difficult unless organizations commit to designing for them explicitly. Without ongoing innovation, advanced therapies risk becoming treatments primarily for regions that already have strong infrastructure.

3. Comparator sourcing: an avoidable bottleneck

Comparator availability has turned into a major source of trial delay. Global shortages, tight pricing controls, and documentation requirements slow starts and force protocol amendments. This isn’t just an external constraint. Comparator strategy is a procurement challenge: late engagement and price-only decisions create downstream risk and extra cost. Patients see the result as trials that are announced but can’t get started.

4. Modernizing Good Clinical Practice: opportunity or missed chance?

GCP modernization encourages risk‑based thinking and proportionate oversight. In theory, it should enable more flexible, more patient‑focused supply models. In practice, new expectations often get stacked on top of the old ones: documentation grows, approval cycles lengthen, and supply teams end up proving control instead of building it naturally into their processes. Modernization that doesn’t simplify the work is simply bureaucracy with new labels.

5. Sustainability: aligned with patient needs or at odds with them?

When sustainability is approached thoughtfully, it helps patients. Better forecasting cuts waste; reusable systems improve control; and localized supply chains can shorten routes and strengthen resilience. When it becomes a compliance tick box, it slows things down. Packaging changes demand requalification work; suppliers may be unable to meet new expectations; and tactical fixes steal attention from long-term improvements. In my opinion, the real challenge is integration – making sustainability choices that strengthen speed, safety, and patient access.

6. Geopolitics and logistics: the new normal

More sponsors are now assuming that disruption is structural, not an occasional inconvenience. Routes shift overnight. Borders tighten. Costs fluctuate. Yet some clinical supply strategies still assume stability. Underinvested contingency plans lead teams to compensate with ever‑larger buffer stocks, creating  more waste but not necessarily more resilience. And patients feel the consequences straight away: missed deliveries lead to missed doses, which erode confidence and increase dropout risk. I can’t overstress: resilience isn’t a “nice to have” – it’s safety.

Accountability: Who Needs To Change What

Improving patient outcomes means different parts of the ecosystem need to evolve:

• Sponsors should build supply feasibility into protocol design and assess partners not just on cost but on reliability and patient‑centered performance. KPIs such as on‑time‑in‑full delivery to the patient, first‑dose‑on‑time, and excursion‑recovery time bring this into focus.
• CROs need to align site activation with supply readiness – lane qualification, comparator availability, depot strategy, and direct‑to‑patient workflows must be integrated, not sequential.
• Manufacturers, packagers, and depots should prioritize flexibility. Late-stage customization, modular packaging, and scalable cold chain capacity help bring therapies closer to the point of need.
• Logistics providers should focus less on speed and more on precision. How quickly a team detects an excursion –  and how quickly they recover from it – matters more than a nominal transit time.
• Sites and investigators play a crucial role in building patient confidence. Clear, simple guidance on handling, storage, and returns prevents small errors from becoming serious issues.
• Technology providers should design systems that prompt action rather than simply collecting data. Exceptions should flow to the right owner with clear service level agreements (SLAs) for follow‑up.
• Regulators and policy makers can help by providing clearer, more aligned expectations across regions, especially for decentralized models where ambiguity is costly.

The Uncomfortable Truth

Clinical supply often presents itself as patient‑centric but, too often, it is only “patient‑aware.” If success continues to be measured mainly in cost, internal efficiency, and procedural compliance, patient outcomes will lag behind. The industry will keep refining the parts while patients wait for the whole system to work.

Putting patients at the center means asking ourselves harder questions:

• Will this decision expand access or shrink it?
• Will it improve continuity or create new risks?
• Will it shorten timelines or introduce delays?
• Will it protect safety without adding unnecessary burden?

Clinical supply can bring new therapies to patients faster or it can quietly slow progress down. The determining factor isn’t technology or regulation – it’s priorities.

Patients already know what the priorities should be. I believe that the real test for our industry is whether we choose to measure our performance by the impact we have on them.

About The Author:

Tom Wells is director in the Life Sciences team at 4C Associates, a London-based consultancy focused on procurement, supply chain, sustainability, and operations. He has previously held regional and global leadership roles in strategic sourcing, procurement, and commercialization with Novartis, Takeda, and Bristol Myers Squibb.