Clinical Supplies Management & Optimization - Key factor to Determine Clinical Trial Success (Co
Clinical Trials – Now:
Innovation and Research has led the science towards more treatment alternatives. Ultimately, Clinical trials are getting complex as more of the treatment options be available in the market and it eventually drives the "Passion to Innovate" at the Pharmaceutical companies. As many resources; including money; are involved in bringing the best molecule from Lab to Patient, the success of Clinical Study determines the final market pricing – to suffice the unmet medical needs somewhere.
Background:
It has been observed that Clinical Supplies Management is one of the most critical aspects of entire Clinical Study Cycle which defines the success of specific molecule. Nowadays; there are multiple Clinical Studies being performed for Biologics and Biosimilars where CSM involves the best calculated Comparator Sourcing, Packaging (as needed basis) and Controlled shipments to sites.
Clinical Supply Management & Optimization (CSM&O):
CSM&O demands detailed understanding of the study design and involvement of the CSM service provider from Protocol design to Site Shipments and Returns. CSM&O plan must be prepared in conjunction with the CSM service provider, as it also ensures the optimized shipment ratios and least of IMP damage / wastage. Accurate plans can even help reducing the unnecessary costs of Sourcing and Shipments which results into less of investment and resource optimization. Hence; optimization of Clinical supplies is a key any Clinical Study and defining market price of the new treatment options to market.