Selecting the Right Partner for Comparator Sourcing

Comparator clinical studies are growing at a rate of 7-8% for last 3-4 years and the trend is expected to remain same till 2017-18. Sponsors expect to run these studies without any issues and obstacles in continuous supplies of these commercial drugs. There are many challenges in the comparator supply chain such as stock-out and overstock, assurance of supply, global supplier network, supplies on-site-on-times, etc. And most of these issues arise if a sponsor chose wrong type of supplier for their need of sourcing comparators. Engaging with a wholesaler can be good for comparator drugs needs in US while engaging with a specialist or clinical supply vendor can be beneficial for comparator drug needs in EU region. Whereas in emerging markets if generic drug are needed for comparator studies and they are easily available in clinical trial site nearby areas then a partner CRO can itself assist in procuring these drugs. So there are plenty of parameters which need to understand before engaging with a type of vendor. This whitepaper will provide a deep analysis choosing appropriate type of vendor for comparator drugs requirement. Comparator Clinical studies are gaining momentum year-on-year due to reduction in innovations in global R&D pipeline. But getting these comparator drugs at right clinical sites at right time is still an uphill task. According to a Tufts institute?s observation in 2012-13 the amount of comparator drugs left un-used for comparator studies by global pharma companies is approximately 30-40% after the trial gets over. This is due to the fact that sponsors are not able to get either batch documents like CoA, CoE, pedigree documents, etc. or storage data documents on time. Some other major issues include unexpected unavailability of branded drugs also leads to insecure supply chain which affects very expensive comparator study programs.