Addressing the Challenges of Clinical Supply Planning and Forecasting: Observations from the Field

Over the past couple of months, we’ve conducted in-depth interviews with several clinical supply leaders and leading consultants about the state of planning and forecasting in the face of increasingly complex and global studies. The input we’ve heard has been wide-ranging and insightful, but through these many hours of conversations, a few common themes have emerged. Let’s dive into these key themes and specific insights shared by these experts, highlighted by the industry’s continued use of outdated tools and manual processes, and the need for more integrated and automated solutions.

The Persistent Challenge of Manual Processes

An overarching common thread in our discussions is the heavy reliance on manual processes and homegrown solutions, like Excel spreadsheets, for planning and forecasting. These methods, while familiar, often lead to significant inefficiencies and errors. Several people pointed out how the manual nature of tasks, especially in smaller companies, limits their ability to scale and adapt to changing trial needs efficiently.

Manual processes are not only time-consuming but also prone to human error, which can have critical implications for clinical trials. Errors in supply forecasting, for example, can lead to either overstocking, which increases costs and waste, or understocking, which can result in delays, interruptions in clinical trials and potential adverse effects on brand reputation. This reliance on manual spreadsheets for tracking supplies and forecasting demands is a significant bottleneck, particularly as trials grow in complexity and scale.

The Push for Automation and Advanced Tools

The need for automation in clinical supply chain management is clear and urgent. Several people emphasized the importance of integrating advanced tools that can handle dynamic scenario planning and real-time data management. Automated solutions, particularly in labeling and forecasting, could significantly reduce errors and improve operational efficiency. For instance, automated labeling systems could manage multiple versions and translations more efficiently, addressing a major pain point noted by some.

Automation can transform the supply chain by streamlining processes and reducing the reliance on manual intervention. Tools such as Interactive Response Technology (IRT) systems and Randomization and Trial Supply Management (RTSM) systems are already in use, but their integration and real-time data capabilities vary widely between studies. Augmenting these tools to support real-time updates and better data integration could enable more accurate forecasting and efficient supply chain management.

Enhancing Data Integration and Real-Time Updates

Integrating forecasting tools with RTSM systems is seen as a beneficial move to enable real-time data updates and management. This integration allows for better scenario planning and forecasting accuracy, which can adapt to changes such as recruitment rates and site activations. The ability to incorporate real-time data is crucial for making timely adjustments to supply plans, as highlighted by discussions on the iterative nature of supply forecasting.

Real-time data integration can help maintain a balanced supply chain by providing accurate and up-to-date information. This capability is particularly valuable in adapting to fluctuations in patient recruitment and site activations, which are increasingly common in clinical trials. With better data integration, supply chain managers can make more informed decisions and reduce the risk of supply shortages or overages.

Collaboration Across Departments

Effective collaboration between ClinOps, Clinical Supply, and other departments is fundamental yet challenging. A common refrain is the need for tools that promote communication and understanding among these groups to bridge gaps and ensure seamless operations. Such collaboration is essential for aligning different priorities and goals within organizations. General sentiment is that Clinical Supply serves as a hub of activity and information during trials, but lacks true collaboration solutions, leading to copying and pasting, and logging in and out of multiple vendor systems that are both internal and external to their organization.

Collaboration challenges often arise from the differing objectives and perspectives of various departments. ClinOps might prioritize ensuring ample supply to avoid trial disruptions while Clinical Supply focuses on cost efficiency and minimizing waste. Bridging these gaps requires robust communication tools and shared goals that align the interests of all stakeholders. For example, implementing a common metric such as a yearly scrap goal can help harmonize the efforts of ClinOps and Clinical Supply, yet this alignment seems to be the exception rather than common practice.

Planning and Forecasting Challenges

Accurate planning and forecasting are critical yet complicated by various factors, including changing recruitment rates, regulatory hurdles, and lack of reliable data. A common refrain is that planning often suffers due to external factors like incorrect regulatory filing strategies, highlighting the need for robust forecasting tools that can adapt to changes. Furthermore, there's a need for integrating projected and actual enrollment data to manage supply effectively, and the importance of tools that can visualize and adjust supply plans dynamically was stressed in our discussions.

The dynamic nature of clinical supplies requires advanced planning tools capable of handling changes in study parameters and patient dropouts. Scenario planning tools that can simulate various outcomes and adjust supply levels accordingly are invaluable; these tools can help in identifying potential risks and developing strategies to mitigate them, ensuring a more resilient supply chain.

Balancing Supply Availability and Cost Efficiency

Balancing the availability of clinical supplies with cost efficiency remains a major challenge. Overages and excess safety stock are particularly costly in the context of expensive biologics, yet the practice of assuming and planning for 25-30% overage is common. This often leads to significant cost overages, and the industry’s multi-billion dollar clinical supply waste costs suggest there’s ample opportunity for improvement with better solutions. Experts suggest a shared goal or metric, such as a yearly scrap goal, to align the objectives of ClinOps and Clinical Supply towards minimizing waste while ensuring supply adequacy is a modest starting point, but more robust tools are necessary to support this alignment.

Managing the tension between supply availability and cost efficiency involves implementing risk management strategies and leveraging advanced tools. For instance, Monte Carlo simulations can be used to model different supply scenarios and assess the likelihood of various outcomes. By understanding the potential risks and their impacts, supply chain managers can develop more effective strategies to balance supply levels with cost considerations.

The Role of External Factors and Flexibility

External factors, such as regulatory changes and geopolitical events, dramatically impact the clinical supply chain. The COVID-19 pandemic exemplifies how sudden global events can disrupt supply chains, necessitating flexible and adaptable systems. The ability to quickly adjust to such disruptions is critical for maintaining the continuity of clinical trials.

Regulatory changes can also pose significant challenges, particularly in managing the labeling and compliance requirements for different regions. Automated labeling systems that integrate regulatory requirements and track submissions across countries can help in maintaining compliance and reducing the risk of errors. Additionally, geopolitical events, such as trade restrictions or border closures, require supply chains to be flexible and adaptable. Developing contingency plans and maintaining a network of alternative suppliers can enhance the resilience of the supply chain.

A Shrinking Pipeline of Talent and the Need for Expertise and Training

There is a notable decline in clinical supply expertise, with newer professionals often lacking the necessary depth of knowledge. This gap leads to reliance on external consultants or Contract Research Organizations (CROs). Experienced clinical supply managers are valued for their ability to manage complex supply chains manually, but there is a push towards adopting technology to bridge this expertise gap.

Training and development programs for clinical supply professionals are essential to building the necessary expertise within organizations. Investing in technology can also help in mitigating the impact of the expertise gap by providing tools that support decision-making and reduce the reliance on manual processes. For instance, AI applications can enhance scenario planning and forecasting accuracy, providing valuable support to less experienced supply chain managers.

Conclusion

The insights from clinical supply chain managers and consultants highlight the ongoing challenges and emphasize the need for robust, automated tools that support effective planning, forecasting, and collaboration. Addressing these issues requires an integrated approach that not only improves efficiency but also adapts to external changes and aligns different departmental goals. As the pharmaceutical industry continues to evolve, leveraging these advancements will be key to enhancing clinical supply chain management, ultimately leading to more successful clinical trial outcomes.

The future of clinical supply chain management lies in embracing technology and fostering collaboration across departments. By addressing the persistent challenges and leveraging innovative solutions, the industry can build a more resilient and efficient supply chain, ensuring the timely and successful execution of clinical trials.