Clinical trials are essential to the development of safe and effective medicines. Yet, behind the scenes, inefficiencies in how clinical trial supplies are produced, labeled, and distributed continue to undermine patient safety, inflate costs, and generate unnecessary waste.

In October 2019, my team presented work on “Demand-driven Clinical Supply Chain: A Paradigm Shift for System-wide Benefits” at the Bio-Supply Management Alliance (BSMA) conference. This work was done in collaboration with Amgen Inc., one of the world’s leading biotechnology companies. The presentation reflected my broader commitment to contributing to public forums focused on strengthening supply chain integrity within the biotechnology/pharmaceutical industry.

At the heart of this work was a simple but powerful question: What if clinical trial supplies were produced and labeled based on actual patient demand rather than long-range forecasts?

The Limits of Traditional Forecast-Driven Models

Most clinical trial supply chains operate on a forecast-driven, make-to-stock model. Products are manufactured, packaged, and labeled well in advance, based on projected enrollment numbers that often change over time. This approach creates several problems:

• Excess inventory when enrollment falls short
• Product scrap when labels expire or protocols change
• Increased risk of labeling errors
• Limited visibility and traceability at the individual product level

In an environment where patient safety and data integrity are paramount, these inefficiencies carry real consequences.

A Shift to Demand-Driven Thinking

The demand-driven or Make-to-Order (MTO) clinical supply chain model represents a fundamental shift in how trial materials are managed.

Instead of labeling and packaging products before demand is known, the MTO approach delays these activities until patient demand is realized. This allows supply chains to respond to real enrollment data rather than assumptions. The analysis and presentation demonstrated that this shift delivers measurable, system-wide benefits.

Tangible Results, Real Impact

By transitioning to a demand-driven MTO model, clinical trial operations achieved:

• A 65% reduction in the use of booklet labels, significantly lowering labeling complexity
• Up to a 14% reduction in finished product scrap, minimizing waste and unnecessary cost
• Fewer labeling errors due to simplified and delayed labeling processes
• Reduced excess inventory across the supply chain

These are not marginal gains. They represent meaningful improvements in efficiency, compliance, and sustainability.

Improving Traceability and Compliance

One of the most important advantages of the MTO model is improved traceability. With less overproduction and waste, tracking and reporting on individual products becomes more streamlined and accurate. This enhances compliance with Good Clinical Practice (GCP) requirements and strengthens the ability to monitor, investigate, and report issues such as deviations or adverse drug effects.

In clinical trials, where every unit matters, improved traceability directly supports patient protection and regulatory confidence.

Why This Matters Beyond Cost Savings

While cost reduction is often emphasized, the true value of demand-driven clinical supply chains lies elsewhere.

Reducing waste lowers the risk of expired or mismatched products reaching patients. Simplifying labeling reduces the chance of human error. Aligning production more closely with actual demand increases agility when trials change direction.

Taken together, these benefits strengthen the overall integrity of the clinical trial ecosystem.

Implications for Emerging Markets

As clinical trials increasingly expand into emerging markets, including across Africa, demand-driven supply chain models offer a compelling path forward.

Infrastructure constraints, importation delays, and enrollment uncertainty make traditional forecast-heavy approaches especially risky in these settings. MTO models provide flexibility, reduce waste, and support more resilient trial operations, key ingredients for sustainable research growth.

A Call for Industry-Wide Change

The insights shared at the BSMA conference reinforced a central lesson: innovation in clinical research must extend beyond the laboratory.

Supply chain design decisions have direct consequences for patients, regulators, and sponsors alike. Embracing demand-driven models is not just an operational improvement, it is a strategic and ethical imperative.

Conclusion

A demand-driven clinical supply chain represents a paradigm shift, one that prioritizes accuracy over assumptions, flexibility over rigidity, and integrity over excess.

By producing, labeling, and packaging clinical trial supplies based on real patient demand, the pharmaceutical industry can reduce waste, improve compliance, and better serve patients worldwide. As clinical research continues to evolve, so too must the systems that support it.

By: Jonathan Baan Naab

Global Partnership Supply Manager at Amgen with a Master’s degree in Biotechnology from Keck Graduate Institute