Clinical Supply Chain Prevention Case Study: Closing Critical Gaps

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 sponsor with a multi-phase clinical program involving complex compounds approached CSC during a critical transition period. Internal turnover had created an immediate need for supply chain expertise while they evaluated new vendors. With plans to expand their global footprint across sites and depots, the sponsor faced multiple operational challenges that threatened study timelines and patient care. The situation demanded a comprehensive review of their supply chain processes and immediate intervention to prevent further complications.

Key Challenges:

• Critical clinical supply chain and forecasting gaps required immediate attention
• Forecast reliability compromised by missing Interactive Response Technology (IRT) parameters
• Qualified person (QP) and country release times exceeded three months
• Ongoing stockouts affected patient and site management
• IRT system required complete restructuring to improve data integrity
• Unnecessarily high distribution costs due to operational inefficiencies

The Solution

By focusing on creating integrated solutions that addressed immediate operational issues while building a foundation for long-term success, CSC implemented a strategic overhaul of the clinical supply chain. This comprehensive approach brought together key stakeholders and streamlined critical processes, establishing a more efficient and sustainable supply chain model.

Key Solutions:

• Developed new forecasting paradigm with refined inputs and more reliable data
• Facilitated collaboration between chemistry manufacturing and controls (CMC), quality assurance (QA), and manufacturing vendors to reduce timelines
• Updated IRT specifications to minimize overage/waste and improve data capture
• Streamlined distribution processes to reduce operational costs
• Implemented improved site and depot management strategies

The Results

With CSC’s expertise, enrollment targets were successfully achieved while sites regained confidence in supply availability. Through improved operational efficiency, the program saw significant reductions in drug waste and data change requests, along with lower distribution costs. Enhanced collaboration between clinical operations, clinical research organizations (CROs), and sites created a more streamlined process. Most notably, after experiencing these key advantages, the sponsor chose CSC as their long-term partner for future needs, deciding not to proceed with alternative vendors or internal resources.

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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.