Managing the Unexpected in Clinical Supply Management

The world of clinical trial supply chains is a constant balancing act. Unforeseen disruptions—from bottlenecks and regulatory shifts to natural disasters and global crises—are par for the course. Imagine managing a complex delivery system where a volcanic eruption grounds shipments, or a political upheaval throws import/export regulations into flux. That’s the reality of clinical supply chain management.

These aren’t just headlines—they’re real-world events that can cripple a clinical trial supply chain. Remember the 2010 Icelandic volcano eruption that grounded flights and halted deliveries across Europe? Or the ongoing challenges presented by the COVID-19 pandemic? The war in Ukraine is another stark reminder of how external factors can disrupt global supply chains. Clinical trial sponsors need to be aware of this inherent unpredictability and be prepared to adapt on a moment’s notice.

The constant threat of disruptions can feel overwhelming, but successfully navigating them is a matter of preparedness—not chance. By implementing proactive strategies, you can transform your clinical trial supply chain into a force of resilience. Here, we’ll explore three key tactics to help your organization prepare for the unexpected and keep your trials on track.

1. Build strong partnerships:
Creating strong and trusting partnerships with your sponsor, third-party vendors, and internal team members at the outset of a clinical trial is essential to effectively navigating the unexpected “hiccups” that occur throughout the clinical study lifecycle.

• Determine and review any potential study-related risks with your sponsor and/or internal team members early in the startup phase, and continually identify and manage any additional risks throughout the study lifecycle.
• Discuss potential risks when onboarding third-party vendors and in the early stages of trial preparation. Doing so can help you understand potential challenges upfront and develop appropriate contingency plans to mitigate issues (e.g., ongoing or foreseeable supply chain issues/disruptions, potential bottlenecks, timeline constraints in drug product manufacturing, etc.).
• Communication is key! When an unexpected and unplanned issue arises, consult with your network immediately to review the situation and quickly determine potential impacts/next steps.

2. Forecast (and re-forecast) clinical supply demand:
Accurate forecasting of drug needs is vital. Work closely with your sponsor and/or internal team members to meticulously assess drug product requirements. Double-check your forecasts to ensure accuracy and adjust them as patient enrollment fluctuates

3. Inventory management: striking the right balance:
Maintaining optimal inventory levels is a delicate dance. Too much stock leads to waste, while too little disrupts patient dosing schedules. Whenever possible, leverage automated inventory management tools for efficient tracking and control of orders, inventory levels, and shipments.

Unexpected events are inevitable. Even the most efficient clinical supply chain isn’t immune to disruptions caused by unforeseen circumstances. By implementing these strategies, you can transform your clinical trial supply chain into a force of resilience, prepared to navigate the inevitable and ensure the success of your clinical trials going forward.