Company insight Outsourcing a comparator
Roshan Fakira, director of global procurement and operations at RxSource, explains the best method for outsourcing a comparator for clinical trials.
How do you know the best way of sourcing a comparator drug? Roshan Fakira: Commercial drug supply for clinical trials can be a minefield to navigate, even with an established procurement team. Understanding the market landscape is paramount to ensure that the trial does not face supply challenges. Almost all sourcing of commercial drugs for clinical trials is done through the established traditional markets in the EU and US. However, there is an emerging Canadian market that can offer a genuine alternative. There are three main ways to source a comparator for a clinical trial, these include: ■ direct from the manufacturer involving a direct link from the manufacturer to the clinical trial
■ central sourcing, which involves wholesalers and utilising a single country’s market and labelling the drug for multiple countries
■ local sourcing, which utilises wholesalers within multiple countries but often the drug stays within the country and requires minimal, if any, further labelling.
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.
counterfeiting due to less links in the supply chain. Sourcing directly can also provide single batches, larger quantities and documentation such as Certificates of Analysis (CofAs). However, there are some points of concern: ■ The disclosure of full clinical trial information: Sponsor companies sometimes do not feel comfortable
“Service providers with access to multiple markets and emerging markets can offer a creative solution that may not have been thought of and can offer a great partnership.”
The approach to sourcing is dependent on each specific trial and its needs, a single formula cannot be applied to all trials. All three approaches have their pros and cons, however, providing the sponsor with as much detail as possible will ensure they choose the best strategy.
Direct from the manufacturer Direct sourcing from a manufacturer is the best way to safeguard against
24 sharing this confidential information.
■ Cost and lead time: Direct sourcing can be more expensive and involve longer lead times due to the additional checks from full disclosure of your trial.
Central sourcing and local sourcing Sourcing from the open market does not involve informing the manufacturer and therefore sharing of trial details is not required. Generally, this approach can
have shorter lead times and the potential for better pricing with the flexibility of sourcing from multiple markets. However, open market sourcing can mean: ■ lack of documentation such as CofAs ■ inconsistent supply of product with no guarantee of a single batch in large quantities
■ shorter expiry dates ■ if local sourcing is required then inconsistent price points and fluctuating availability must be considered. This can be balanced out with import, export and re-labelling requirements.
Is Canada an alternative market for sourcing and why? Yes, Canada is an alternative sourcing market to supplement or replace US product requirements. Canada can offer: ■ US equivalent drug for a fraction of the price written in the English language.
■ comprehensive economic trade agreement with the EU allowing easier importation and release of Canadian drug versus the US equivalent
■ the Canadian market does not often Clinical Trials Insight /
www.worldpharmaceuticals.net
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