Comparator Sourcing in Clinical Studies (Part Two of Two)

Due to the free movement of trade, European medicinal wholesalers are not obliged to exclusively supply domestic markets and can also export products to foreign clients or sell to sponsors conducting clinical trials. The market is highly volatile with prices and availability of drug product changing frequently. Understanding the rules of trade and commerce is, therefore, a key requisite when dealing with comparator suppliers and their wholesalers in this sector. Although sponsors like to plan drug requirements often over a year in advance, wholesale stock options seldom remain available for longer than a few weeks. Sponsors rarely understand this, assuming that all stock options are being quoted from innovator channels where endless reserves of product are stored in huge warehouses. Avoiding wastage through accurate supply and demand forecasting has now become a critical issue for pharma companies in both clinical trial and commercial settings. This means we are seeing more ‘just-intime’ manufacturing and less stockpiles of comparator drugs available in the wholesale sector. A comparator vendor must have a baseline understanding of pricing and ongoing drug availability in each market and be able to negotiate the right price for the product on the sponsor’s behalf. One essential factor when selecting a comparator supplier is that they have a wide selection of wholesale suppliers – each of whom can supply the same comparator product. In this way, if one or several wholesalers fail to supply, there is always a back-up option in place.