Managing the Unexpected in Clinical Supply Management

By Shannon Woodall
Senior Clinical Supply Manager

  • 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.

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