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The clinical research industry has historically operated with a focus on effectively and efficiently delivering therapies that will benefit patients. Now, sustainability and environmental considerations are increasingly on the agenda as we recognize the role our industry plays in contributing to environmental challenges. Estimates suggest that the healthcare sector is responsible for 4.4% of global greenhouse gas (GHG) emissions.¹ As clinical research continues to globalize and grow at pace, there is a risk that this figure will escalate unless mitigation strategies are actively included in corporate strategies.

As we understand our unique responsibility in sustainable drug development, we are leveraging evolving tools and processes to improve operational efficiencies and reduce our climate impact across the development continuum. One significant opportunity is within supply chain management. Approximately half of the wider industry’s CO₂ emissions stem from fuel combustion in the supply chain, contributing to the supply chain’s 11% share of the global healthcare-related CO₂e (carbon dioxide equivalent emissions) footprint.¹

Applying a holistic approach to supply chain strategy can help industry stakeholders tip the scales toward sustainability across various decision points, including design and management, vendor relationships, protocol and refined needs forecasting. Here, we outline some key practices that contribute to a more successful and sustainable clinical supply chain management system.

Plan, simplify and adapt across the lifecycle

Developing thorough strategies that account for all aspects of the supply chain while remaining agile and responsive is crucial. Planning should cover the details from protocol design through vendors, site, and patient elements to help optimize processes with sustainable solutions. Simplifying the process reduces the risk inherent in supply chain complexity, providing mutual benefits for sponsors by optimizing efficiency, reducing waste, and helping to mitigate costs at key points.

A successful strategy is flexible. Every study has different phases of its lifecycle, as does supply chain. Certain types or phases will be more complicated than others, therefore the strategy will need to flex to manage each phase appropriately. A collaborative Clinical Supply Project Manager (CSPM) can be vital in rapidly pivoting the strategy to fit evolving needs and conditions impacting the program.

Early engagement with protocol design

It is best to begin sustainability efforts early. We advise engaging with the clinical supplies team as early as possible to assess study protocol and proactively drive efficiencies. At this stage, a seasoned clinical supplies team can advise sponsors on optimal kit configuration to reduce packaging and components, suggest more sustainable materials to reduce waste and identify early adjustments that can carry benefits downstream.

Manufacturing and shipping schedules, patient visit schedules and overall distribution strategies can be assessed to ensure leaner systems, minimize transportation-related emissions and further reduce risk of waste.

End-to-end accountability

A company’s strategy planning inevitably encounters the “make or buy” decision. As few companies possess all necessary manufacturing, quality, and distribution capabilities in-house, certain activities are outsourced to vendors.

Accountability for implementing more environmentally conscious processes should extend throughout the supply chain, internally and within vendor relationships. Vendor performance management systems should capture elements of both efficiency and effectiveness to achieve reduced inventories, avoidance of stock-outs and less waste to reconcile and destroy at study close-out.

When contract research organizations (CROs) hold direct vendor contracts, we can drive change in multiple ways, including pre-engagement due diligence to ensure vendors align with ESG values including on issues such as labor, diversity, and environmental sustainability. We can also write ESG metrics into contracts for accountability and include training, implement audits and assessments to reinforce these goals.

For example, ICON conducted 120 supplier audits in 2023 and actively engaged suppliers to advance their ESG efforts, resulting in formal emissions reduction plans with partners in the largest contributing areas. We also work with third parties to report data about sustainability, GHG emissions, and diversity status and classifications for additional accountability and transparency.

Leverage innovation

Utilizing the abundant data and innovative technologies evolving in the clinical research arena is vital to maintaining quality, cost effectiveness, and a positive end-user experience while pursuing more sustainable clinical research. Technologies supporting telehealth and decentralization help reduce transit-related GHG contributions at site and patient levels, while digital solutions like our Interactive Response Technology platform allow CSPMs more fine-tuned control over the process within a single custom-built platform, including automated resupply and threshold resupply and prediction capabilities.

Leveraging data in new ways can also provide insight into enrollment trends, kit consumption patterns and waste risk potential at key stages of the supply chain lifecycle, which can be used to improve needs forecasting and more resilient strategies. Similarly, feedback from sponsors and sites can clarify demand forecasts to better align with enrollment projections and ensure the right products reach the right patients at the right times.

A promising pilot program

Kit wastage across the industry contributes to landfill and other environmental challenges. Efforts to address kit waste include kit recycling, redirecting surplus kits and waste from landfills to under-resourced healthcare services. ICON has implemented a more proactive approach in our kit forecasting pilot program that spans 900 sites across 40 countries through multiple pharma partnerships.

In the clinical supply chain, there are different methods and datasets available. We developed a bespoke database and applied a novel interrogation of data on protocol schedules, indications, and enrollment rates to provide insight into consumption patterns, site-specific stock levels, and uses. The result is a refined kit forecasting system that guides ordering processes to reduce idle inventory and mitigate waste, which can be further enhanced with lean operating models and efficient, just-in-time kit manufacturing.

This pilot program has reinforced the understanding that risk of waste varies across studies based on enrollment strategies and protocol and has highlighted recruitment as the most high-risk period for kit waste due to the inherent variability at that stage. Clear, continuous feedback between sites, sponsor, and CRO is vital to refining this strategy for tighter margins that both mitigate kit waste and optimize operations and improve cost effectiveness in clinical supply management. At the time of writing, these programs have shown up to 20% reduction in kit wastage.

A proactive pivot, focused on the patient

While pursuing sustainability, patient-centricity remains paramount. We still define our successful supply chains management around metrics of delivering the drug on time to the right patient, no missed patient visits, no emergency shipments, and zero stock-outs that could potentially jeopardize the integrity of the trial or cause an "interruption of care or death” for patients.²

A resilient and sustainable supply chain is especially important in expanding equitable access to essential medicines in low- and middle-income countries. Tackling these challenges requires a commitment to technology-assisted supply chain management, investment in local infrastructure and training, and expanding into collaborative public-private partnerships that have typically been limited in environmental governance.³

Advancing technology and innovative approaches have opened opportunities for more sustainable solutions within clinical research that mitigate climate impact and still support patient-centered development programs. Proactive mitigation within the supply chain holds the potential for higher impact as a key area of GHG emissions contribution. By adopting a holistic approach that optimizes each component of the process, the clinical research industry can collectively drive progress and pivot toward a greener future while continuing to support patient-centered clinical research.

About the Authors

Kelly Corkey, Director, Clinical Supplies Management, IRT, ICON

Kelly has over 15 years’ experience in healthcare marketing, manufacturing, and clinical project management. She is Director of Clinical Supplies at ICON, where she is responsible for setting the strategy for clinical supply chain projects across a portfolio of biotech and pharma studies. She has a keen interest in public health, particularly how the pharmaceutical industry can simultaneously influence and solve the disparity between population need (in terms of burden of disease), and R&D. She has a degree in microbiology and holds various project management and Chartered Management Institute qualifications in management and leadership. She is currently studying for a Masters in Global Health Policy.

Leonard Wee, VP, Global Supply Chain, Laboratories, ICON

Leonard Wee is Vice President of Global Supply Chain for Laboratories at ICON.He has over 23 years of experience in supply chain, with a focus on supply chain resiliency and risk mitigation, customer centric service offerings, E2E supply chain, global footprint optimisation, and cost and capital efficiencies.

References

1. Prof Manfred Lenzen, PhD; Arunima Malik, PhD; Mengyu Li, PhD; Jacob Fry, PhD; Prof Helga Weisz, PhD; Peter-Paul Pichler, PhD; et al. The environmental footprint of health care: a global assessment. The Lancet Planetary Health. Published: July, 2020 DOI:

2. Pasquet A, Messou E, Gabillard D, Minga A, Depoulosky A, Deuffic‐Burban S, et al. Impact of drug stock‐outs on death and retention to care among HIV‐infected patients on combination antiretroviral therapy in Abidjan, Côte d'Ivoire. PLoS One 2010;5(10):e13414.

3. Willetts, E., Grant, L., Bansard, J., Kohler, P.M., Rosen, T.,Bettelli,P.,& Schröder, M. (2022). Health in the global environmental agenda: A policy guide. International Institute for Sustainable Development. https://www.iisd.org/publications/health-global-environmentagenda-policy-guide.