Comparators are increasingly being used in clinical trials to test the efficacy of investigational medicinal products compared to the existing market product. As the number of clinical trials across the globe grows, the demand for reference drugs, or comparators, is mounting.
This demand puts pressure on comparator sourcing partners to source enough comparator products within the required timeframe and budget for the clinical trial design.
Comparator sourcing partners use knowledge of global markets to choose the most appropriate sourcing strategy, whether it is local, central, market or manufacturing sourcing. Local comparator sourcing is a strategy many sourcing partners use, due to the availability, efficiency, and affordability of supply.
Local comparator sourcing is a sourcing strategy whereby the comparator product is bought within a single country and used in a clinical trial within the same country. The product avoids import and export charges and regulations, which can speed up the clinical trial supply chain and save costs.
When implementing a local sourcing strategy, comparator sourcing partners liaise directly with manufacturers in the trial country, to source products at the right quantity and within a suitable expiry for the length of the study.
Depending on the supplier’s relationship with the manufacturer, the product can be shipped directly to the trial site, depot, or patient, compared to sourcing from the open market and struggling with availability of supply.
A significant challenge when sourcing comparators from global markets is delivering drugs on time so they can be used in the clinical trial within the product expiration date. Typically, local comparator sourcing enables sourcing partners to obtain products quicker than they would via other sourcing strategies. Complications caused by Brexit can cause further delays when importing and exporting comparators into other countries within the required timeframe.
As the product is sourced and used within the same country or region, comparator products are available much sooner. This is because the products do not have to be exported and imported into a different country, pass through customs, and meet regulatory requirements, and reach the depot site before being ready for use within the trial itself.
Documentation, such as certificates of analysis, is crucial to show the chain of custody from the source to the destination. Translating documents into another language may result in important regulatory requirements being misinterpreted.
Sourcing and supplying comparators in the local language to clinical trial sites and trial participants is incredibly advantageous. Language barriers cause significant delays to the clinical supply chain and require translators to produce all documentation and labels in the local language of the trial and its participants. When the documentation is already in the local language, all stakeholders can readily read the documentation and product labels to understand how the product is to be used.
Reducing delays within the clinical trial supply chain caused by product shortages, availability of supply, import and export, shipment and delivery, regulatory requirements can help make significant cost savings. Sourcing partners can leverage relationships with local manufacturers and suppliers to understand timelines and market knowledge, and overcome demand and product shortages, to obtain products cheaper than on the open market.
In addition, bypassing import and export requirements can reduce the amount of paperwork and documentation required, which can lead to potential tax savings. This is furthered by reducing the number of distribution networks required to transport the product from country to country, again leading to tax savings.
Local comparator sourcing provides many advantages and opportunities for reduced timelines, efficient supply, and cost savings. It must be noted that whilst it is a highly effective strategy, it is not a one size fits all solution. Comparator sourcing partners, like Clinical Services International, will take the most appropriate route to improve the speed and agility of your clinical trial.
We leverage our global network of over 95 manufacturers to source high-quality comparator drugs and ensure the efficient, effective delivery of your studies. We improve trial success rates by securely sourcing comparator drugs in short supply with the longest expiry, ensuring comparators are available for trial participants at the right place and time.
Contact us to discuss how we source comparators to ensure the successful supply of your clinical trials.
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