Clinical trial supply chains are a key component of drug development,
ensuring investigational medicinal products are manufactured, packaged, distributed, and delivered to trial sites in an efficient and compliant manner. The global clinical trial supply and logistics market, valued at $3.98 billion USD in 2024, is expected to nearly double by 2033, driven by increasing demand for innovative therapies, particularly for chronic and rare diseases.

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Managing clinical trial supply chains presents significant challenges,
particularly for early-phase biotech and pharmaceutical companies with limited in-house resources and expertise. Key challenges include: 

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• Efficient data management

• Timely batch certification

• Reliable temperature-controlled storage and shipping

• Compliant secondary labeling

• Vendor management and project coordination

• Regulatory compliance

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Without a strategic approach, these challenges can lead to costly trial delays, compliance risks, and compromised patient safety. However, by adopting a rigorous approach to centralized data management, qualified temperature-controlled logistics, validated secondary labeling, and structured vendor approval, companies can streamline operations and mitigate risks.

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This whitepaper explores these key challenges and provides actionable solutions to help emerging biotech and pharmaceutical companies navigate supply chain complexities, maintain compliance, and ensure seamless trial supply