Pharma services and solutions

Supply chain: Clinical supply management

The challenge

Pharmaceutical and biopharmaceutical companies face significant challenges in reducing time to market for new drugs. Tightened regulations, growing consumer expectations for safety and efficacy, and globalization of markets are lengthening lead times in clinical trials and increasing costs.

Industry response

To remain competitive while enhancing drug portfolios, companies have adopted multi-pronged strategies, affecting supply chains:

• Mergers and acquisitions, resulting in a changing mix of new drug development across different therapeutic areas and consolidation of trial sites and manufacturing resources
• Agency collaboration, leading to increased adoption of an "adaptive clinical trial model" and other statistical techniques to mitigate the risks and prohibitive costs of developing new drugs
• Innovative drug development techniques, such as co-development and quality by design (QbD) to trim drug-approval lead-times and decrease time and effort for scaling up to commercial manufacturing
• Operational efficiencies through right sourcing and improving distribution infrastructure

Impact on clinical supply management

Industry response has transformed clinical supply from oversight of a domestic, linear process into management of a complex network of global demand and supply lines, addressing additional challenges:

• Cross-functional collaboration from trial design through execution
• Demand forecasting accuracy and visibility
• Lead time management in quality release of clinical supplies
• Lot expiration and label management
• Inventory management at manufacturing sites and depots
• Global trade compliance
• Technology and information management
• Organization, talent and change management

These challenges create significant opportunity for clinical supply chain to drive efficiencies, lower costs and reduce lead times for drug launches.

How we can help you

One of the most important factors in successfully conducting clinical studies is the efficient management of clinical-study supplies. Our experienced pharmaceutical, life sciences, and medical device supply chain professionals can help you develop a sound strategy for reengineering internal processes and integrating them with leading technologies. Our supply chain optimization and performance improvement services address many components of supply chain management, including metrics, RFID-enabled cold chain, logistics, outsourcing, global trade compliance, pooled and on-demand supplies, integrated trials and operations planning, demand-driven supply networks, lean manufacturing, contract manufacturing, lot traceability, and inventory visibility.

Common services include

• Assessment of clinical supply chain management, covering business processes, organization, technology, and performance
• Development of strategy and roadmaps for business transformation, including technology enablement
• Design and development of a hierarchy of clinical supply chain metrics to measure and improve performance
• Evaluation, design, and deployment tools for global clinical supply chain integration and management
• Design, development, and deployment of a continuous improvement program, including change management