Comparator sourcing is a complex challenge in a globalised market says Clinigen
George told Outsourcing-pharma.com that maintaining a full audit trail for the products to which candidate pharmaceutical products are compared is critical from both regulatory standpoint and from the perspective of drugmakers which do not want drugs to be diverted into the “grey market.”
“It is quite complex to get manufacturers to agree to supply [comparators for] clinical trials because… they are effectively supplying their competitors,” he said adding that “what they definitely don’t want to happen…is the drugs they supply ending up in the grey market.”
The key challenge going forward – George continued - will be balancing the need for shorter supply chains with the increasing globalisation of the clinical research sector, which he believes will require both knowledge of both international trade and clinical research.
