Drug Expiry Date Extension Case Study: Ensuring Treatment Continuity

At Clinical Supply Consulting (CSC), we specialize in transforming how pharmaceutical, biotech, and medical device companies manage their clinical supply chains. Through our case studies, you’ll discover how our innovative solutions can help you overcome challenges, boost efficiency, and fast-track your time to market.

The Challenge

A pharmaceutical sponsor running a Phase 2B multi-center, randomized, double-blind trial faced a critical supply chain crisis. With frequent stockouts occurring and no documented plan for managing expiry dates, the sponsor risked treatment interruptions for their patients. While their product was on analytical stability to receive additional shelf life, and manufacturing was scheduled, the quantities wouldn’t meet immediate study demands due to delayed enrollment. This complex situation required immediate intervention to prevent study disruption and maintain patient treatment schedules.

Key Challenges:

• Multiple investigator sites and primary depots in the US and UK required expedited expiry date extensions
• No existing standard operating procedures (SOPs) for expiry date management at the sponsor or site level
• Blinded investigational products (IPs)—both active and placebo—complicated the process
• There was an urgent need for expedited production runs and resupply shipments

The Solution

Clinical Supply Consulting (CSC) stepped in with a comprehensive approach to address the sponsor’s immediate needs while implementing long-term solutions. Our team developed a strategic plan that combined regulatory-compliant labeling procedures with practical site-level implementation. We focused on minimizing disruption to ongoing trials while ensuring all sites had proper documentation and training to handle expiry date extensions effectively.

Key Solutions:

• Developed and implemented comprehensive SOPs and guidance documents for expiry date management
• Created regulatory-compliant expiry auxiliary labels for IP clinical extension labeling
• Provided specialized training to CRA/site monitors on the expiry date extension process
• Coordinated resupply shipments to sites and depots that were unable to perform extensions and/or required additional IP

The Results

Thanks to CSC, the study continued without pauses or interruptions, and no patients missed their scheduled treatments. All supplies were successfully extended or replaced before their original expiry dates, maintaining the integrity of the trial. The sponsor received approval to proceed with Phase 3, demonstrating the success of our supply chain management strategy. Most importantly, CSC’s proactive approach ensured zero treatment interruptions, showcasing our ability to handle complex supply chain challenges while maintaining patient care as the top priority.

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Clinical Supply Consulting (CSC) delivers the clarity and confidence sponsors need to keep trials on track. Our consultants bring decades of sponsor-side and operational expertise to every engagement, helping pharmaceutical and biotech companies streamline global clinical supply chains and accelerate development programs. We provide seamless solutions that span early- to late-phase studies, always aligned with GxP, ICH guidelines, and EU regulations.

CSC offers flexible services designed around your trial’s needs, including end-to-end embedded support, IRT UAT services with sponsor-grade script writing, SOP generation and alignment, and transparent pricing for sourcing. With deep industry knowledge and a proven track record, CSC strengthens your clinical supply chain, making it inspection-ready, cost-efficient, and built for success.