The role of risk management in building resilient clinical trial supply chains

The concept of resilience in clinical trial supply

Imagine a clinical trial, years in the making, suddenly facing disruption that jeopardizes patient access to vital medication. This is the reality many pharmaceutical companies face, highlighting the critical need for resilience in Clinical Trial Supply.

The pharmaceutical industry, like many others, faces a landscape fraught with challenges. According to the 2024 Gartner Board of Directors Survey, the most significant barriers to growth include recession risks, economic/geopolitical uncertainty, and regulatory changes. For Clinical Trial Supply (CTS), these external pressures are compounded by a unique fourth challenge: the inherent unpredictability of clinical trials themselves.

Clinical trials are extremely strategic for pharmaceutical companies, as they  directly drive the company’s long term viability, directly impact patients' lives, and help drive the world’s knowledge of diseases and treatments . Ensuring success means delivering the right drug to every patient, on time, in full and in perfect condition. As a consequence, it is primordial that clinical trials supply chain professionals incorporate resilience in the way they manage their activities. If we look at supply chains in general, expert consensus is that less than 10% of the companies will succeed in implementing end-to-end (E2E) resilience by 2026.

The daunting conclusion is that even though everyone recognizes the importance of resilience, very few actually achieve it, especially in clinical trial supply where uncertainty is much bigger.

Shedding the light on supply chain resilience

According to Gartner and ASCM, supply chain resilience is the ability to avoid, absorb or recover from the business impact caused by a disruption. A truly resilient supply chain should:

1. Avoid potential risks impacting operations, by anticipating shifts in demand or supply

2. Absorb the consequences of the risk, either through a broader range of possible solutions and/or through a faster deployment of said solutions

3. Recover from the consequences of the risk by getting back to the original planning, avoiding restarting it from scratch

A 2022 Gartner survey reports that many organizations are trying to achieve resilience to mitigate disruptions by:

• Increasing inventory buffers at any level for key SKU

• Expanding the number of locations/network alternatives

• Adding suppliers or boosting production

Taken individually, these strategies could ensure a robust approach towards unpredictable demand and supply events. However, as these approaches are often taken in a decentralized way, it often results in a suboptimal resilience setup, either in the intensity of the response (e.g. the quantity/capacity increase), in its location, or simply because some of these strategies are redundant.

Implementing resiliency grows exponentially difficult with the complexity of the supply chain. Clinical trials supply chains are some of the most complex supply chains to handle (they are the perfect example of the VUCA normalization). It's therefore no surprise that implementing a resilient clinical trial supply chain is challenging.

This complexity can be addressed through a combination of methods and processes, ideally supported by advanced digital tools.

Move away from "one-plan fits-all" methodology

Ask any clinical  trial manager whether their last demand plan actually happened, and the likely answer will be no. Clinical demand is very volatile. Patients enter studies anywhere, anytime, and enrollment timelines are frequently delayed. The same uncertainty applies to the supply side. In drug development, a batch may fail a QC control or an expiry update can shift due to testing not reaching regulatory standards.

Tackling these issues has always been challenging. Anticipating them is even more so. A common method to anticipate them is worst case planning. But even that can fall short. Why? The answer is actually twofold:

1. The definition of a worst case actually depends on more factors than just demand/supply uncertainty. For instance, expiry events or geopolitical crises are too often overlooked. These two alone can drastically shift how supply will be impacted. Regardless of the additional quantities planned, if not anticipated, they’ll disrupt the strategy.

2. Worst case planning puts tremendous pressure on the operational team, for sometimes little resilience-return on investment because inventory is not strategically positioned. Indeed, producing tons of inventory without knowing where to send it is pointless.

Rather than following the traditional approach“plan for the worst hope for the best”, i.e. a single point forecast (a worst case-one), it is more effective to look at a range of possibles and combine the different responses together. Indeed, planning for risks individually leads to overstated covers. Instead, taking a holistic view on risk responses allows to anticipatively design responses that are a fit for multiple risks.

However, adopting the “planning within a range” methodology is a long journey. It requires significant efforts and persuasion to overcome ingrained habits and legacy ways of working. Additionally, planning against a wide range of possibilities is in contradiction with the way reality unfolds: a single scenario.

Leverage digitalization to anticipate planning risks

In a VUCA world, by definition, assumptions change constantly. Take, for example, patient enrollment: projections made just a week prior may have been particularly ambitious, necessitating significant adjustments to the release schedule and distribution strategy. Then, a sudden communication from the CRO announces a drastic shift in patient locations, disrupting both distribution and release plans. As patients are now receiving kits labeled for a different region, the entire strategy must be revised. This may involve cancelling shipments and renegotiating with the CDMO to split the release across two distinct labeling groups, adding complexity and operational strain.

As stated earlier, planning for a range of possibles would have alleviated this. The cherry on the cake would be to actually have a method, a system, efficiently stress-testing the plan against assumptions changes. Hopefully, nowadays, digitalization turns this ambition into reality.

Digital planning tools enable the processing of significantly larger volumes of data in a structured manner. They also capture the volatile and interconnected nature of assumptions over time. Furthermore, they facilitate multi-dimensional plans analysis, not only making the trial work but also, cost, CO2, workforce & capacity utilization amongst others.

All in all, the use of these tools enhances understanding of the complexities and implications of potential supply-side trade-offs.

Ensure to have a structured approach to monitor & manage globalized risks

The life of a CTS planner is often punctuated with one thing that comes back over and over: firefighting - navigating urgent, high stakes questions - like “how to get these kits to patients when flooding shuts down key distribution routes”). This happens randomly, might last for an unknown amount of time and have varying levels of impact on the global CT network. Consequence? Each urgency is addressed as best as possible, as quickly as circumstances allow, using whatever tools are available, which are rarely standardized, while hoping the issue is resolved before the next one rises.

Anticipating risks doesn’t happen overnight, yet, putting the right people around the table to consistently assess the global geopolitical situation, and subsequently the potential consequences on CTS management is somewhat cheap. With such a committee in position, there is a direct tangible benefit in the ability to feed and steer discussions with clinical teams, ensuring that visibility on the risks is shared at all levels.

Once a risk-watching committee recurrently meets and identifies risks, going the extra mile and ensuring a comprehensive, robust and consistent way to proactively (and sadly but truly, reactively manage the risks is the only logical step.

Summing it, up, the key actions of a risk-watching committee are as follows:

1. Oversee global events and their potential impact on CTS

2. Review the current and emerging risks, as well as the responses designed (if any)

3. Monitor the efficiency and effectiveness of the risk mitigations actions

4. Ensure the mitigation actions are followed at operational level

By embedding these principles of structured risk management and adaptive planning, clinical trial supply teams can transform uncertainty into strength, ensuring uninterrupted patient care and achieving the steady progress that makes pharmaceutical companies successful.