Company insight


Effective comparator sourcing amid a pandemic


While clinical trials have always faced challenges, technological innovation, decentralised models, and the Covid-19 pandemic are adding to the complexity. Forming strategic relationships with partners such as Clinigen Clinical Supplies Management can be key for clinical trial sponsors to plan a reliable and flexible approach to sourcing comparator drugs.


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dentifying and sourcing suitable comparator products requires a comprehensive strategy, especially given the rise in demand for comparator drugs driven by growing interest in investigating combination therapies and the need to show better performance over existing treatments.


The pandemic has underlined the importance of being agile to adapt to changes, especially in trial supplies. Selecting a sourcing partner with global coverage, long-standing local relationships, market knowledge and buying power is essential for difficult-to- source medicines.


Comparator sourcing challenges Getting approval and support from a manufacturer for a product to be used as a comparator often involves long lead times and restrictions, including limitation on quantity. Yet, support for sourcing comparators is often sought too late in the project. In addition, choosing a partner that does not have an extensive understanding of global and local regulations around drug sourcing, and import and export requirements, can put the trial at risk.


delayed and even set back by several years due to the pandemic, resulting in significant product overages.


The Covid-19 pandemic has increased the complexity of sourcing comparator drugs.


helped; different regulations can result in a change of products being purchased. It has become increasingly difficult to source large quantities of product for clinical trials as local market needs have taken precedence, and lockdowns have led to import and export restrictions. Given the current circumstances, different purchasing models should be


“Clinigen Clinical Supplies Management provides tailored comparator sourcing solutions that are flexible and cost-effective. With a global depot network in place, comparator products are always on hand.”


The impact of Covid-19


The Covid-19 pandemic has added to the complexity of sourcing comparator drugs. The fact that it has coincided with the impact of Brexit on supply chains has not


Clinical Trials Insight / www.worldpharmaceuticals.net


considered. Demand-driven sourcing is needed, but often challenging to implement due to long lead times. More flexible sourcing is of the essence. Many trials have already been


Navigating complexity successfully Planning for comparator sourcing should happen early, during study design development before the start of a project. Working together with a partner with local entities, where products can be purchased, received and held in own depots, will help guarantee fast delivery. For trials in Europe, locations in both the UK and EU will ensure a Brexit-proof strategy and a choice of supply routes to cover study demand. Delivering materials on time and at the right locations to meet the specifications of each trial also requires customised solutions. With agreements in place with manufacturers, prices are locked in and availability is assured over time, based on demand and patient recruitment for each project.


A comprehensive approach The need for flexible comparator sourcing strategies has never been more apparent than it is today. The right partner will devise a strategy with built-in flexibility that ensures the expected changes during a trial can be managed successfully.


Clinigen Clinical Supplies Management provides tailored comparator sourcing solutions that are flexible and cost-effective. With a global depot network in place, comparator products are always on hand. From exclusive distribution agreements to on-demand sourcing, Clinigen pioneers new supply strategies to provide necessary speed and flexibility to the supply chain, even during the pandemic. ●


www.clinigencsm.com 29


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