Existing clinical trial supply models are facing a number of challenges – increased market competition, growing trial complexity, a significant rise in global trial initiations, and pricing pressures are just some of the factors necessitating strategic shifts in how supply models operate.
Past research indicates that up to 80% of clinical trials fail to meet their enrolment targets, a factor that renders traditional supply chain forecasting approaches dicier than before. Meanwhile, broader shifts such as US President Donald Trump’s imposition of tariffs are creating further volatility and uncertainty in the pharma space.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
With factors such as the rise in cold chain biologics, tighter timelines, and R&D pressures, stakeholders in the clinical trial supply chain ecosystem cannot afford to operate in a silo. Product delays, delivery issues, and site closures are just some of the issues that can burden supply chain efficiency. To address them, integrative collaboration and technology are of rising importance in mitigating issues as they arise while maintaining end-to-end oversight.
With all of these challenges in mind, Clinical Trials Arena spoke with Arnaud Dourlens, head of clinical supply chain operations at Sanofi, to learn what advancements and technological innovations can drive operational resilience and mitigate ongoing pressures in the clinical trial supply chain.
This interview was conducted at Arena International Events Group’s 2026 Clinical Trial Supply (CTS) conference, which took place in Barcelona, Spain on 24 and 25 February.
This interview has been edited for length and clarity.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataRoss Law (RL): How do clinical supply models need to evolve to meet the demands of increasing trial complexity?
Arnaud Dourlens (AD): Rising complexity in terms of the regulatory landscape, different updates across different geographies and the shifting nature of trial enrolment are occurring at the same time.
Therefore, the present model of standard variability in a known environment needs to adapt to one that is prepared for higher levels of variability. For this, supply chains need to be developed with greater optionality in mind. Whereas today, we used to get quite standard models and operating flows for one network and one type of need, the future will have to handle various ways to serve the same need. For example, moving to various geographies can be an option.
RL: What factors can help support this evolution?
AD: To support this evolution, digitalisation has a key role to play in connecting various data sources to get a sense of what’s happening in real time. We have a lot of data available, but it is not always well-qualified, well-defined, or even accessible. To address this challenge, leadership needs to evolve to cross boundaries and be able to interact with all stakeholders in the clinical supply ecosystem, meaning the vendors and different internal stakeholders at the pharma level, to be able to connect all datasets and data points, and clarify the use of that data. This leadership advancement is a fundamental prerequisite. If we don’t get this level of foundation for our data, leveraging artificial intelligence (AI) will only provide limited benefits.
The second aspect is in leveraging AI to quickly identify signals that we were missing in the past and translate those signals in terms of demand shift, risks, or threats across the whole network, and directly get insights to support decision-making towards, for example, adjusting a supply network’s configuration.
RL: What supply model shifts are needed to support general market challenges such as competition and cost pressures?
AD: Recent years have seen a huge shift in the overall clinical trials ecosystem. Looking at the current market, there is a higher concentration and competition among all the different pharma companies, and they are nowadays more often focused on similar disease areas, indications, and therefore patient populations.
The direct result of this is an increase in the total number of clinical trials, and alongside this reality, everybody is looking for more speed. The level of competition in similar indications is also leading to a paradigm in which new competitors arrive with a clinical trial that may compete directly with the asset someone put on the market within two to three years, whereas this was more like eight to 10 years in the 1990s.
This is not happening in silos, and is also happening with an explosion in the cost of R&D. These factors are pushing complexity in decision making, because the commercial benefits are eroding. The challenge of this commercial benefit is directly translating into the clinical supply chain, meaning more pressure, less room for errors, and more scrutiny around risk being taken in regard to the probability of a respective clinical programme’s success.
Addressing these issues means setting up a clinical supply chain with the ability to quickly change direction and configuration as needed – something that is not the case with all existing supply chain models that have grown accustomed to a more predictable, stable environment.
RL: What supply model adaptions are needed to deal with broader global risks such as geopolitical fragmentation and policy unpredictability?
AD: To answer this, I want to highlight Germany’s approach to pricing policy. This has evolved recently to a model where they’re offering a bonus on the price they’re going to sell your drug at if more than 5% of your clinical patients are German on the drug you submit.
This suggests that we are moving in an environment when the rules of the game, country by country and region by region, are moving and changing, and can impact the footprint or the strategy of a clinical trial.
To meet these shifts, the clinical supply has to evolve accordingly. These shifts need to happen quickly. Given the level of risk and exposure we have, between the conflict in different countries and the potential for major disruption around international logistics, we also need to think differently about the wisdom of centralised supply models. There is now a shift in the paradigm in terms of balancing between efficiency and resilience.
In the future, it is my belief that those who will be the most successful in terms of clinical supply, but more broadly in terms of clinical development, won’t only be the ones who are performing with the highest level of efficiency. Those who success will be those with the right balance between efficiency and resilience of their overall network, and the ability to keep activities going, whatever is happening across the world.
For this, supply chain models need to evolve towards a reliance on different regions and vendors and take a stronger approach to partnerships. This should be achieved by risk mapping and having a clearer oversight of risks impacting both sponsors and vendors, with increased knowledge-sharing in this sense, to providing a better means of mitigating individual stakeholder risks that can more broadly affect the overall supply chain.
RL: What, in your view, is the key advancement needed for existing clinical trial supply models?
AD: For years, clinical supply chain models pushed the flow of product based on forecasts. With the level of variability we’re facing nowadays, particularly in trial enrolment, this model is no longer suitable.
We ultimately need more sharing and common understanding between the clinical teams and the clinical supply chain teams. At the end of the day, we are working with the same information; we have joint scenarios between what’s happening at the patient enrolment and clinical supply distribution operation plan level. To make the best use of this knowledge, we need to work on the same datasets and systems, all with a view to achieving the most suitable balance that ensures operations progress smoothly and risks are dealt with in a timely manner, for the betterment of patients and ecosystem stakeholders alike.
Interested in attending or sponsoring an upcoming Arena event? Complete the form below and our team will be in touch.
