With the increase in complexity and cost of global clinical studies, the amount of biogenetic or biosimilar also rises. The availability of different comparator products is responsible for the making and breaking of different clinical trail’s supply chain.
Timing is important
Perhaps one of the simplest methods of reducing risk during comparator sourcing procedure is to start making plans earlier usually in the protocol design segment. A complete planning and clinical studies is very important as the drugs can be easily available from a wide range of sources across many geographies. Advance planning requires some time in order to.
· Provide availability, assess to proper options and boundaries for sourcing the preferred comparator.
· The evaluation of regional variations of various comparators which involves API concentration, visual aspect, strength, dosage form and regulatory agreements in intra country associated to the equivalence of different comparators.
· The sourcing options are reviewed for reformulation, packaging, relabeling requests and blinding.
· It also helps in creating an essential quantity or volume and a proper delivery schedule.
· A complete evaluation of comparator cost and price is also observed.
The exposure towards regulatory and financial ricks got increased if the comparator sourcing is measured as a series of various transactional events.