Comparator sourcing; clinical supply chain issues in Russia

Russia, one of the BRIC (Brazil, Russia, India and China) nations, has a huge potential for comparator clinical trials with current global share of 2%-4%. Sponsors generally use highly expensive branded comparator drugs for Global multicenter clinical trials (GMCTs). But managing the supply chain is an uphill task for sponsors in this geography, according to a new thought leadership whitepaper from Beroe Inc, a global provider of customized procurement services, authored by Rahul Sodhi.

Introduction

Drying R&D pipelines and guidelines from the US Food and Drug Administration have forced pharma companies to enhance their focus on comparator studies. According to a recent study, in 90% of comparator trials sponsors use branded drugs. Certain parameters like high patient randomization and cost, need for robust and streamlined supply chain, issues related to sourcing comparators from manufacturers, etc, make the overall process relatively challenging for sponsors. In all the geographies sponsors need a network of reliable supply chain vendors for end-to-end services for comparator sourcing.