Using your RTSM to Implement Drug Pooling Strategies: Maximize Flexibility and Reduce Costs

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Term to Know:

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Drug Pooling

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Drug pooling is a supply management strategy in clinical trials that maintains a centralized inventory of investigational products, allowing supplies to be shared across multiple sites, studies, or patient groups until they are needed. Instead of pre-allocating stock to specific locations in advance, drug pooling enables just-in-time distribution, reducing waste, improving supply efficiency, and optimizing trial costs.

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Modern Clinical Supply Chain Challenges

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Today’s clinical trials are complex global operations, spanning multiple regions with distinct regulatory requirements, logistical hurdles, and unpredictable patient enrollment patterns. Managing clinical supplies effectively means balancing efficiency with patient needs while navigating import/export regulations, language-specific labeling, and local sourcing challenges. Without a well-managed approach, these complexities can drive up costs, increase waste, and delay treatment availability.

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To address some of these challenges, trial sponsors are exploring more flexible supply strategies that allow them to adjust to real-time study demands. One such strategy is drug pooling, which centralizes inventory and enables investigational products (IP) to be shared across multiple sites, studies, or patient groups. While not suitable for every trial, drug pooling can reduce waste, improve supply utilization, and lower costs—particularly when managed through a randomization and trial supply management (RTSM) system that dynamically tracks and allocates inventory.

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‍Understanding Drug Pooling

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Drug pooling is a comprehensive strategy to fix many current clinical supply chain issues. It connects otherwise siloed segments of the clinical trial supply chain to make the entire system more automated, dynamic, and forecasting-based. The approach can solve both oversupply and under-supply scenarios with a buffer stock of clinical trial materials. Drug pooling can be implemented at various levels of the clinical supply chain, at the depot level where supplies are centrally stored and distributed as needed, or at the site level, where supplies are kept undedicated until required for specific patient, site, or study needs.

The dynamism of drug pooling allows for more efficient allocation of resources, minimizing waste and ensuring that supplies are available when and where they are needed most.

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The Role of RTSM in Drug Pooling

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While drug pooling offers clear advantages, its success depends on having the right technology in place. Managing pooled inventory across multiple sites and protocols requires real-time visibility, automated supply decisions, and precise tracking—all of which are enabled by an RTSM system.

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An RTSM system ensures that pooled supplies are allocated efficiently based on real-time patient enrollment, site needs, and protocol requirements. By integrating drug pooling with RTSM, sponsors can:

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• Reduce the risk of stockouts by dynamically reallocating inventory where it is needed most.
• Minimize waste by preventing unnecessary shipments and reducing expired product.
• Improve supply logistics by allowing for just-in-time distribution instead of rigid pre-allocation.

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For large Phase III programs with multiple trials and global sites, depot-level pooling can significantly reduce manufacturing, labeling, and shipping costs. When combined with site-level pooling, these efficiencies increase even further, ensuring that supplies remain available as trial demands evolve.

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Key Elements for Implementing Drug Pooling

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Successfully implementing drug pooling requires careful planning and the right technology to manage supply allocation, inventory tracking, and compliance considerations. Three critical elements include:

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• Common Supply Platform – Standardizing packaging, dosage forms, and inventory management across studies ensures that supplies can be used across multiple protocols, maximizing flexibility.
• Flexible Labeling Strategies – Multi-protocol labels or just-in-time labeling allow supplies to remain undedicated until they are assigned to a specific protocol, improving adaptability while meeting regulatory requirements.
• RTSM System Optimized for Pooling – The RTSM system acts as the central hub for managing pooled supplies by tracking inventory, automating supply allocation based on real-time demand, and supporting compliance with study-specific supply strategies. While other operational factors contribute to the success of drug pooling, an RTSM system provides the necessary visibility and control to ensure that supplies are distributed efficiently and in alignment with trial needs.

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Without an RTSM system capable of handling pooled supplies, managing a drug pooling strategy efficiently becomes significantly more challenging.

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When to Use (and Not Use) Drug Pooling

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Drug pooling can be an effective strategy for optimizing clinical supply management, but it’s not the right fit for every study. Understanding when pooling doesn’t make sense and when it does can help sponsors make more informed decisions.

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When Drug Pooling May Not Be the Best Fit

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In some cases, the complexity of drug pooling may outweigh its benefits, including:

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• Trials with no site overlap or significantly different protocols. If studies operate independently with no shared investigational product, the efficiency gains from pooling may be minimal.
• Highly predictable demand. When supply needs are stable and easily forecasted, a more traditional supply model may be sufficient.
• Low-cost investigational products. If the drug itself is inexpensive, the effort required to implement pooling may not justify the cost savings.

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When Drug Pooling is an Advantage

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Drug pooling is especially valuable in complex trials with dynamic supply needs, such as:

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• Global trials with fluctuating enrollment. When patient recruitment varies by region, pooling allows sponsors to shift supplies where they are needed most, reducing waste and stockouts.
• Multi-protocol programs. Studies that share a common formulation, dosage, or comparator can benefit from pooled inventory, reducing the need for separate supply chains.
• Limited or high-cost drug supply. When investigational product is expensive or in short supply, pooling helps sponsors maximize available inventory and avoid unnecessary overproduction.
• Adaptive trial designs. Pooling supports trials with protocol amendments or evolving treatment arms by enabling greater flexibility in supply allocation.

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An RTSM system plays a central role in making pooling successful by ensuring real-time inventory tracking, automating supply allocation based on actual patient enrollment and site demand, and supporting flexible labeling strategies to maintain regulatory compliance. By leveraging RTSM, sponsors can determine where pooling is the right fit and implement it with confidence, ensuring efficient supply distribution while maintaining full control over trial logistics.

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A Powerful Clinical Supply Strategy

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In 2023, researchers cited drug pooling as one of the primary strategies needed to improve global accessibility to novel cancer treatments. By adopting this approach, clinical trial sponsors can achieve greater efficiency, reduce costs, and ensure timely and accurate patient dosing. As the industry continues to evolve, embracing innovative strategies like drug pooling will be essential for maintaining the pace and success of clinical trials in a competitive global market.  

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Schedule a quick demo with Endpoint Clinical to learn more about how our solutions can optimize your clinical supply chain.

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