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The success of any clinical trial is underpinned by a well-planned and smoothly functioning supply chain model. In a dynamic and ever changing global regulatory environment for clinical trials, providing an innovative, solution-oriented supply chain strategy and planning process can ease the startup phase for the trial. To ensure that the clinical supply chain meets healthcare and regulatory standards, the planning process should begin far in advance, involving all potential stakeholders and vendors.
Five key focus areas should be considered when planning a customized clinical supply management solution: understanding the specifications for the investigational product (IP), taking a centralized approach, improving the accuracy of enrollment forecasting, streamlining sourcing and procurement, and selecting relevant technology. These are discussed below:
1. Understanding specifications for the IP: The most important initial step is to fully understand the nature of the product and to ensure that appropriate regulatory checks have been carried out for all regions where the trial will take place. For example, certain drug substances or products may be banned from importation into some countries based on local food and drug agency and health ministry requirements. A thorough understanding of the manufacturing process, primary packaging and labeling, and stability data will inform planning for the handling, storage and distribution of the study drug. Reviewing regulatory documents related to all clinical trial material – such as the qualified person (QP) release certificate, clinical outcome assessment (CoA), certificate of confidentiality (CoC) and material safety data sheet (MSDS) – will help in selection of a suitable storage facility and courier services with appropriate licensing to handle the products.
2. Taking a centralized approach: A sustainable and robust supply of clinical trial material can be ensured by selecting a vendor that serves as a central depot to fulfill the regional needs of the trial, while also offering compliance with good manufacturing practice (GMP), good distribution practice (GDP) and regional regulations. Often, the labeling and packaging for multiple regions can be performed at one central location before distribution to local facilities, offering a consistent process. This will help build time- and cost-effectiveness and can avoid waste of product, especially Investigational Medicinal Product (IMP). Ideally, the selected central depot should be a standalone vendor offering a full range of services, including import management, sourcing, packaging and labeling, and storage and distribution (S&D). To build efficiencies in the flow of supplies, a “trial in a shipment” approach (shipping ancillary material and study document in a single shipment) can reduce the number of steps involved in receiving and handling of the trial material at the site.
To ensure that the clinical supply chain meets healthcare and regulatory standards, the planning process should begin far in advance, involving all potential stakeholders and vendors.
3. Improving the accuracy of enrollment forecasting: Enrollment forecasting is a critical skill, meriting the time taken to fully understand the expected pattern of enrollment for each trial and enabling improved supply management planning. Priority should be given to supply chain strategy to meet the needs of the study design, population size, treatment frequencies and randomization patterns; this can lead to increased accuracy of production and supply scheme projections. This should take priority over production and material procurement planning. A sustainable and adjustable supply scheme with initial and resupply quantities enables control over the flow of the supply throughout the trial and minimizes overage need.
4. Streamlining sourcing and procurement: The selection of ancillary materials for a trial can be complicated by the web of distributors and great variety of clinical supply manufacturers available. Local clinicians can often provide guidance on appropriate sources based on best medical practices for a specific therapeutic area. All supplies must comply with local regulatory requirements on labeling for “use in clinical trials,” and be allocated to the appropriate level of materials classification; for example, certain products purchased for trials in the European Union are required to carry a ‘CE’ mark. Shelf life and packaging should be taken into consideration when making major purchases for clinical trials, since these factors can impact the sourcing cost and timelines, as well as minimizing waste and the need to return and destroy unused supplies. Non-IP products can be well managed via regulated resupply volume and same-day shipment. Time can be saved by choosing either a central or local sourcing strategy based on regional requirements; these can increase the chances of quick procurement by limiting the need for imports. Other solutions such as issuing patient-level prescription cards for comparator drugs can also substitute for traditional sourcing methods.
5. Selecting relevant technology: The global and cross-functional nature of trials require the selection of a robust and reliable technology solution to gain real-time data, comprehensive reporting, monitoring at blinded and unblinded levels, and traceability of clinical trial material for routine management of the supply chain. A platform that can serve as a communication medium for all stakeholders is key to a successful supply chain model. An interactive response technology (IRT) is arguably the most useful monitoring tool for IP management. While there are many options, an IRT system that is user friendly, interfaces with the electronic data collection system, and integrates with the drug and ancillary depot portal, can be a powerful control tower for the trial’s supply chain.
Attention to these five key focus areas can form the core of a successful, proactive planning approach to clinical trial supply management – helping maximize the chance of clinical trial success.
Saadia B Chaudhry is a business leader in the healthcare & Life Science industry, with 16 years of experience providing solutions-oriented leadership in managing Phase I-IV global trials, including eight years focused on clinical trial supply management with strong background including financial acumen, operational excellence and team management. She has a bachelor’s degree in Chemistry from the University of Illinois at Chicago, and a master’s degree in Biotechnology from Harvard University.
