COVID-19 elevated the critical nature of global supply chains and their importance to the healthcare market. Supply and distribution strategies had to be adapted to mitigate impacts that arose due to lockdowns, reductions in cargo flights, lack of materials inventory, staffing issues and other setbacks. Trial sponsors, their clinical research organizations, study teams and other key stakeholders such as, vendors, had to work collaboratively to ensure trial continuity without adding cost and time. 
 
Looking ahead, sponsors need to stay well-prepared for the next potential roadblock. Risks such as material or drug shortages, natural disasters or another major public health issue have the potential to de-rail a trial or at the very least, cause major disruption to otherwise carefully laid plans. There is also an overarching need, in general, to be better at reducing waste of life-changing treatments that patients need. This makes an agile, thorough clinical supply chain approach critical for sponsors who plan to strengthen efficiencies in future trials while also anticipating challenges. To optimize supply management strategies, there are several focus areas sponsors can keep in mind for future trials, with a strong supply chain management team as the foundation of the plan. 
 
Cost-effective supply and distribution strategy
An experienced clinical supply chain management team will oversee efforts to take a detailed view of all process areas that add cost and time while striving to plan a quality supply delivery. Creating a tailored, study-specific supply and distribution plan can help improve efficiencies. Key elements of a comprehensive plan, include: 

• Interactive Response Technology integration to ensure accurate tracking of shipment frequency, distribution costs and adequate supply reaching patients. An IRT allows for end-to-end visibility for each relevant stakeholder’s responsibilities, including supply chain managers requiring a bird’s-eye view of investigational product monitoring to address issues quickly. For example, unpredictable enrollment or study changes can create restocking needs for sites for which IRT platforms can provide real-time supply optimization. These systems are intended to seamlessly integrate with vendor systems and to patient data via data management platforms.  
• Forecasting inventory to ensure there is appropriate IP manufacturing for the trial’s lifecycle so there’s enough drug available for patient visits and to reduce wastage at trial completion. Using real-time data and analytics, teams can improve supply management decision-making.
• Efficient distribution through cost- and time-effective logistical channels, which can be thoroughly monitored through an IRT platform. 
• Temperature excursion management at a kit and shipment level and closely auditing the trail allows for electronic accountability and integrity of maintaining quality contemporaneous temperature-controlled product movement, whether it is going to depot, site or being returned. 
• Drug expiry management to ensure reduced volumes of expired drugs returned upon trial closure.

Process visibility is especially important for cell and gene therapy and other novel design trials, where manufacturing, supply chain and logistics, including temperature management, can be laborious and intricate and can lead to treatment wastage, if not planned for and executed efficiently.

Supply chain management: a core member of the study team
From trial design to IP return and trial closure, open collaboration among trial stakeholders involved in the end-to-end process is crucial for effective supply chain workflow and management. As such, it is important to consider clinical supply chain managers as a key function in the study team, just as investigators, site teams, operational leads and others are. 
 
Because studies are unique in design, execution and goals, breaking down information silos is especially important. For example, sponsors and their CRO partners are seeing the benefits of decentralized trial (DCT) solutions to trial cost and timelines. But how do sponsors considering integration of DCT components account for supply control processes that differ from traditional studies without adding burdens to sites, patients and supply chain teams? 
 
For one, as patients are able to perform certain trial tasks remotely, functional leads need to identify all potential risks early in the process to support safe and quality study activation and protocol conduct and ensure all relevant stakeholders are kept informed. Risks can include, delayed arrival of supplies meant for sites or patients, mismanaging temperature control of IPs and failing to determine needs around patient monitoring with home health professionals. 
 
Working alongside therapeutic, clinical, regulatory and other key stakeholders, experienced clinical supply chain managers can review the trial protocol and help ensure best practices are in place, including clearly establishing all specific roles and related communication expectations throughout the trial lifecycle well before trial start up to help mitigate risk, avoid logistical challenges and reduce costs. 
 
These trials and other novel models require complex operational coordination. Experienced supply chain managers stay closely aligned with external partners (e.g., transportation and materials supply) to ensure seamless systems integrations for ongoing data reconciliation and supply tracking purposes. 
 
Strengthened stakeholder oversight 
When sponsors are deciding what to look for in a clinical supply chain management partner, it is key to consider expert teams who are fully integrated into the study process, as noted above. It is also important that their supply chain oversight approaches are flexible and equipped to quickly make adjustments, primarily relaying on in-house cross-functional solutions to manage processes without delay and ensuring external partners are well-qualified and informed to integrate into the team. 
 
When planning and executing supply chain strategies, sponsors can ask themselves: 

• Where is the supply chain team located, and which party is best placed to perform this function (e.g., sponsor, CRO or contract manufacturing organization)?
• What unique challenges has the supply chain team overcome with innovative approaches (e.g., COVID-19)?
• How close is the supply chain team to the heart of the study and related study team? 
• How does the team qualify and seamlessly incorporate external partners into the process? 
• In what capacities (e.g., supply transportation across regions and sites) does the team work with external partners? 
• How does the team ensure all internal and external partners are keeping within regional regulatory compliance in individual roles? 

Given the varying intricacies within a manufacturing-to-distribution-to-user workflow, there will be some level of risk to clinical supply management processes. The key goal for sponsors and partners is to find every possible way to manage risks without adding time, budget and drug waste while ensuring process efficiencies are kept center stage. In a complex drug development landscape, advanced planning and making sure IP and study materials are in place to effectively maintain trial continuity for patients in need will be critical.

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