Maximizing Clinical Trial Success Through Strategic Expiry Date Management

Expiry date management of investigational products (IPs) can make or break a clinical trial’s success. While teams dedicate extensive resources to patient recruitment, site selection, and protocol design, the strategic oversight of product shelf-life often takes a backseat. This operational component directly impacts trial timelines, budgets, and patient dosing schedules. When mismanaged, it can lead to costly resupply runs, site delays, and even patient dosing interruptions. Effective expiry date planning ensures regulatory compliance and uninterrupted supply across global sites—making it a cornerstone of successful trial management. The cost of poor planning in this area can ripple throughout the entire study, affecting both patient care and data quality. 

Every clinical trial relies on the fundamental requirement that investigational supplies maintain their integrity from manufacturing through the last patient’s final dose. This isn’t just a quality consideration—most countries legally require expiry dates on clinical labels. Success depends on close coordination with your analytical team, which establishes storage conditions and shelf-life through carefully planned stability testing schedules. Understanding your stability pull points and data availability timeline is crucial for maintaining continuous supply throughout the study. Early alignment on these schedules allows teams to anticipate and prevent potential supply gaps, while ensuring all regulatory requirements are met across different regions. 

Forward-thinking clinical trial managers recognize that expiry date management goes beyond basic compliance. Successful programs prioritize proactive stability planning that accounts for potential study delays while ensuring seamless integration with interactive response technology (IRT) systems. This includes configuring critical supply parameters and implementing robust standard operating procedures (SOPs) for depot and site-level updates. Teams must consider the capabilities of their supply chain partners, including depot relabeling capacity and site-level procedures for managing expiry updates. Understanding country-specific requirements for expiry extension adds another layer of complexity that must be addressed early in the planning process. 

Transparent collaboration between clinical supplies and analytical teams is key. By maintaining open dialogue and sharing information proactively, teams can ensure uninterrupted IP delivery and patient dosing. This partnership enables teams to optimize stability data availability and address global regulatory requirements efficiently. Regular communication channels and established escalation pathways help teams respond quickly to emerging challenges. When analytical and clinical supply teams work together effectively, they can often accelerate stability data availability to support urgent supply needs and prevent potential stockouts. 

The most successful trials treat expiry date management as a strategic priority rather than a compliance checkbox. Through clear processes, early planning, and proactive risk management, organizations can reduce costs, prevent delays, and ultimately support successful trial completion. This requires establishing clear roles and responsibilities across functions, maintaining detailed documentation of extension processes, and developing contingency plans for potential supply challenges. Regular review of expiry date management strategies ensures teams can adapt to changing study needs while maintaining compliance.  

At CSC, we partner with clients to implement these best practices and ensure smooth clinical trial execution, drawing on our extensive experience managing complex global studies. Contact our experts to develop a customized expiry date management strategy that will keep your trial on track and compliant.