Company insight
provide CofAs but can be used for export for trials that do not require them.
Thinking outside of the traditional markets can not only allow for a more stable untapped supply of drugs but can also reduce the procurement cost and ultimately drive down the price of the clinical trial.
What are the pitfalls of sourcing drugs for clinical trials and how do you overcome these? When planning clinical trials there are often areas that are overlooked. Below are some points that require consideration prior to selecting a sourcing partner or market for procurement: ■ Underestimating lead-times: Often commercial drug procurement is overlooked early in the trial planning stage with an expectation that the product will be available when required. Sometimes packaging and labelling runs are booked in advance and the expected delivery date is set prior to developing a robust sourcing
strategy. Lead times can be longer than expected due to market consumption fluctuations, manufacturing issues.
■ Regulatory environment: Import restrictions, labelling requirements and country of origin all fall into this category. The use of alternative markets or generics when compared with innovator products must be considered prior purchasing. Equally local sourcing may seem the most economical option at first, however complications can still occur if auxiliary labelling is required for the local market.
■ Documentation requirements: Understanding the release and import/ export requirements for all countries helps determine the strategy.
■ Product changes: Some markets offer the same drug but it can be packaged differently, and this can impact planning or pre-purchased components such as blisters or bottles.
■ Inventory and expiry date management: Often searching for the maximum expiry in the market is deemed as the
best strategy for flexibility, however, planning and a comprehensive understanding of consumption rate can often provide better flexibility, such as products sorted by date, which can provide cost saving if the product is being consumed immediately.
If commercial drug sourcing is outsourced, it is vital that a service provider with the skill and knowledge to drive the trial forward is selected. It is similarly important that whichever service provider is selected can procure from markets suited for the trial.
What is clear is that service providers with access to multiple markets and emerging markets can offer a creative solution that may not have been thought of and can also offer a great partnership. It is key for a successful trial that the service provider works in partnership with the sponsor to ensure continuation of supply even during unpredictable market conditions. ●
www.rxsource.com
Clinical Trials Insight /
www.worldpharmaceuticals.net
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