Challenges in the Global Clinical Supply Chain

Key challenges facing the global clinical supply chain, including increasing trial complexity and regulatory requirements, while highlighting proactive risk management and cross-functional collaboration are strategies to maintain clinical supply reliability and keep clinical trials on track.

The Global Clinical Supply Chain (GCSC) ensures the components that support the execution of clinical trials, such as investigational products, study materials, and supporting information, reach patients and clinical trial sites around the world. Sites are facilities where clinical research involving human participants can be carried out. In order for clinical trials to run smoothly and successfully, adequate clinical supply is essential. This includes many components and factors, such as vendor management, ancillary supply forecasting, trade compliance, and clinical planning.

Increased endpoints and sites have made clinical trials more complex, creating more elements that the clinical supply chain needs to adapt to. However, making changes in the clinical supply chain can often trigger regulatory review. It is crucial that regulatory compliance is maintained at all times, as failure to comply with regulations can lead to trial failure and increased costs. 

Although larger trials can enhance patient recruitment and diversity, they also add complexity to the clinical trial process and create additional challenges. When a clinical trial is conducted across multiple countries, there are differences in regulations, laws, procedures, logistics, protection of participants, and transportation requirements, among other factors. 

Another challenge in the GCSC is the lack of real-time visibility, which makes it difficult to track shipments throughout the supply chain and can contribute to higher costs and delivery delays. Investments in advanced tracking technologies, such as Radio-Frequency Identification (RFID) and Global Positioning System (GPS), have improved visibility. RFID helps monitor inventory and detect shortages before they affect patient enrollment. These technologies help identify products and provide real-time information on the status and location of supplies, and some companies are already integrating artificial intelligence into their visibility platforms.

Another important consideration is temperature control throughout the clinical supply chain. Temperatures must be maintained within the required study range during transportation. Maintaining appropriate product temperatures is essential to preserving the quality and stability of investigational products. Inadequate temperature control can compromise product integrity and lead to adverse effects and potentially even trial failure. The most common solutions for cold chain packaging are insulated shippers with dry ice, gel packs, or phase-change material panels to maintain the required temperature range. Other solutions include active temperature-controlled containers, which are electrically powered units that maintain the temperature in the appropriate range, and cryogenic shippers, which use liquid nitrogen in a porous matrix to maintain extremely low temperatures. 

Changes in clinical supply can arise at any point in the chain, and if they aren’t managed well, they can cause downstream effects. Managing these changes well requires a model to detect and respond to change before reliability is lost. Earlier risk sensing and stronger cross-functional decision-making can help control downstream disruptions and maintain clinical supply reliability. The goal is no longer only to execute the original plan efficiently, but to preserve study continuity and keep clinical trials on track when conditions change unexpectedly.

What is ICH E6(R3)?

ICH stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH’s mission is to achieve greater harmonization worldwide to ensure that safe and effective medications are developed in the most resource-efficient manner. ICH E6(R3) is the international guideline for Good Clinical Practice (GCP) in clinical trials, establishing standards for designing, executing, recording and reporting clinical trials to protect participants and ensure that trial results are reliable. This guideline reinforces the importance of proactively identifying risks and maintaining product quality and availability throughout clinical trials. As clinical trials increase in complexity, ICH E6(R3) will help guide how trials are conducted to ensure they remain efficient and ethical while supporting the adoption of a flexible framework for clinical chain supply management.

References

1. Clinical trial site. Iliomad Health Data. 
2. Takeda Post-Doctoral Fellowship Programs. Industry Pharmacists Organization. 2026.
3. Clinical Supply Under Pressure: Navigating Uncertainty and Disruption. IQVIA. 2026.
4. 5 Challenges in Clinical Trial Supply Chain and How to Overcome Them. Proventa International. 2022.
5. Ndebele P, Blanchard-Horan C, Shahkolahi A, Sanne I. Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings. J Acquir Immune Defic Syndr. 2014;65 Suppl 1(0 1):S29-S31. doi:10.1097/QAI.0000000000000037
6. Radio Frequency Identification (RFID). U.S. Food and Drug Administration (FDA). 2018.
7. Clinical trial supply management: the complete sponsor guide to the IMP supply chain. PharmaEduCenter. 2026.
8. E6(R3) Good Clinical Practice (GCP). U.S. Food and Drug Administration (FDA). 2025.

*Information presented on RxTeach does not represent the opinion of any specific company, organization, or team other than the authors themselves. No patient-provider relationship is created.