A large global Pharma Sponsor conducted a Phase III program in oncology, involving 30 countries.

The study medication for this program was a large molecule drug with a short shelf life with limited availability. Comparator was a feature of the study design which required supply along with the study medication. This could not be supplied at site so procurement was required for the global study.

The limited availability of study drug and the high cost of comparator meant that wastage had to be kept to an absolute minimum.  A supply chain design was developed that focused on reducing the impact of recruitment and minimizing any potential excursions of the comparator.  Fisher Clinical Services negotiated a supply agreement for comparator to ensure prices were fixed, allowing overall costs to be controlled and ensuring initial slow recruitment would not result in expired stock being wasted. 

The team developed a centralized approach to storage and distribution. They identified three main distribution hubs which could service the majority of sites and countries. In addition, languages were grouped in order to produce an effective multi language label set. These were applied in a refrigerated environment ensuing zero excursion was achieved for all products throughout the preparatory process. Fisher Clinical Services worked with investigators and courier companies within defined transit times and to schedule times medication could be received at site.  This allowed study drug and comparator to be dispatched from the distribution centers only when patients were successfully screened -ensuring all dispatched medication was sent to successfully recruiting sites. In turn this made the replenishment of the distribution centers more efficient and  minimized wastage throughout the supply chain.

Fisher Clinical Services worked closely with the IVR team to forecast drug supply needs at a site level.  This allowed shipments to be consolidated where appropriate, controlled distribution costs without over committing medication to sites.

Fisher Clinical Services achieved continuity of supply to site within pre-determined timelines while ensuring no product was lost due to distribution to non- or slow recruiting sites. A fixed comparator supply agreement ensured initial small purchase quantities did not lead to increased costs.  Based on comparison to a similar study conducted by the sponsor, wastage of both study drug and comparator were reduced by over 50%.