Before an investigational medicinal product (IMP) reaches patients in a clinical trial, it must navigate a complex web of supply chain operations. From manufacturing and labeling to storage, shipping, and regulatory approvals, each step must be executed optimally to ensure trials run smoothly.
Despite its crucial role, clinical trial supply chain management is often underestimated – until something goes wrong. A delayed shipment, labeling error, or temperature fluctuation during transportation can delay a trial, increase costs, and impact patient safety.
Here, we outline the most significant challenges in clinical trial supply chain operations and provide actionable strategies to overcome them.
1. Data Management and Batch Certification
Clinical supply chains often involve multiple stakeholders, including manufacturers, testing labs, distributors, and trial sites. This means that data can become fragmented across different systems, making it difficult to track supply chain operations and opening up the risk of missing or incomplete datasets, which can cause compliance issues. Moreover, it hinders the ability of a Qualified Person (QP) to certify a batch for compliance with Good Manufacturing Practice (GMP), delaying batch release (1,2). Moreover, data problems can disrupt trial timelines and impact patient enrolment and treatment schedules, which is particularly problematic in cases where recruitment is challenging, for example, in rare disease trials (3).
Organizing data in a single centralized data management system enhances transparency and streamlines batch certification as well as regulatory submissions and audits. Implementing digital tracking tools, like PROMAP, ensures real-time visibility of essential documents, enabling QPs to review and certify batches efficiently and reducing the risk of errors and delays (4).
2. Cold Storage and Shipping
Many IMPs, including biologics and cell and gene therapies, require ultra-low temperature storage and shipping. However, factors like customs delays, temperature fluctuations during transit, and dry ice sublimation pose risks to product integrity. This puts drug efficacy and safety at risk, which can invalidate entire batches and cause significant trial setbacks (5,6).
To safeguard products during transit, optimized cold chain logistics processes such as pre-approved customs clearance, stability-tested packaging, and real-time temperature monitoring should be put in place (5).
3. Secondary Labeling
Clinical trials often span multiple sites dispersed across different geographic regions, and consequently, each site can have distinct labeling and language requirements7. Moreover, for temperature-sensitive products, labeling must be done without thawing, which is challenging since many labels fail at ultra-low temperatures (6).
Improper labeling can lead to compliance failures, batch rejections, and delays in patient dosing. Therefore, validated labeling strategies like cryo-compatible and just-in-time labeling – which allow for flexibility without compromising product integrity – should be implemented. Additionally, collaborating with experts can help ensure adherence to country-specific labeling requirements.
4. Vendor and Project Coordination
Sponsors often rely on multiple third-party vendors, such as contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), and logistics providers. While engaging experienced third parties is necessary, without proper coordination, misalignment can occur, which can lead to costly delays in trial timelines.
Implementing project management tools and validated standard operating procedures ensures alignment across vendors. Moreover, we recommend maintaining a small core network of trusted partners (with proven track records) to ensure quality and efficiency in projects.
5. Regulatory Compliance
Regulatory requirements vary significantly across regions and governing bodies, and misunderstanding the relevant requirements can cause delays in approvals and result in noncompliance8,9. Regulatory noncompliance can have serious consequences, including regulatory holds, rejected shipments, and financial penalties, delaying trial progress and potentially causing reputational damage.
To avoid regulatory challenges later down the line, it is essential to engage regulatory specialists early in the trial planning process to help align global compliance strategies.
Conclusion
Navigating clinical trial supply chains can be complex, but by engaging experts – like those at PRONAV Clinical – and implementing the right strategies, companies can minimize disruptions, maintain compliance, and ensure trials run smoothly.
Our recent whitepaper explores these challenges in greater depth and provides clear and actionable solutions to help biotech and pharma companies optimize supply chain operations for success.
Ready to learn more about how you could streamline your clinical trial supply chain?
References
1. The future strategy for batch testing of medicinal products in Great Britain – consultation document. GOV.UK. Accessed January 31, 2025. https://www.gov.uk/government/consultations/the-future-strategy-for-batch-testing-of-medicinal-products-in-great-britain/a8693799-6b5a-446c-8200-0cf6f58d421d
2. Patel KT, Chotai NP. Documentation and Records: Harmonized GMP Requirements. J Young Pharm. 2011;3(2):138-150. doi:10.4103/0975-1483.80303
3. Videnovic A, Pfeiffer HCV, Tylki-Szymańska A, et al. Study design challenges and strategies in clinical trials for rare diseases: Lessons learned from pantothenate kinase-associated neurodegeneration. Front Neurol. 2023;14:1098454. doi:10.3389/fneur.2023.1098454
4. Zhao W, Durkalski V, Pauls K, et al. An electronic regulatory document management system for a clinical trial network. Contemp Clin Trials. 2010;31(1):27-33. doi:10.1016/j.cct.2009.09.005
5. Sykes C. Time- and Temperature-Controlled Transport: Supply Chain Challenges and Solutions. Pharm Ther. 2018;43(3):154.
6. Rayfield WJ, Kandula S, Khan H, Tugcu N. Impact of Freeze/Thaw Process on Drug Substance Storage of Therapeutics. J Pharm Sci. 2017;106(8):1944-1951. doi:10.1016/j.xphs.2017.03.019
7. Mishra S, Venkatesh M. Rare disease clinical trials in the European Union: navigating regulatory and clinical challenges. Orphanet J Rare Dis. 2024;19(1):285. doi:10.1186/s13023-024-03146-5