An Alternative Logistics Approach Realizes Cost and Performance Efficiencies in Asia Pacific
Regional Hub model delivers control, compliance & visibility
Our client, one of the top major pharmaceutical companies with research priorities aligned to significant global health needs – diabetes, heart disease, cancer and mental health – had a high number of studies already in progress in the Asia Pacific region. The Sponsor’s focus on particular therapeutic areas indicated that many more studies would be planned for this region. The Sponsor, having concerns with its current distribution approach, recognized the need to review its distribution model for existing and planned studies in an effort to realize efficiencies in cost and performance. Country specific affiliates
Traditionally all packaging and labelling functions were carried out in the North American and/or European facility and then transported as complete supplies to the many “country specific affiliates” across the Asia Pacific region. One obvious concern pointed to the varying levels of quality standards from one affiliate to another, as many did not consistently adhere to global GMP/GDP standards. In addition, this traditional model presented other challenges:
- High inventory overage & poor inventory visibility
- IMP wastage
- Non-refundable tax & duty payments upfront
- Additional fragmented costs, e.g. emergency deliveries
- Exposure to risk of pilferage, order delivery accuracy and timeliness of shipments
- Varying destruction costs & processes for each country
Historically there were many parties involved in managing the Asia Pacific trials – the Sponsor and Fisher Clinical Services teams globally and in the Asia Pacific region. A plan was put in place for all parties to work together as one team to carry out a high level of analysis of all current and planned clinical trial studies, to evaluate all aspects of the trial from start to finish, including packaging, labelling, storage, distribution models, returns and destruction. The team was tasked with realizing cost and performance efficiencies across the entire clinical trial process while adhering to trial timelines. This thorough analysis resulted in an alternative approach from the outset.
Regional Hub Approach
The new logistics model dictated the set up of an “Asia Pacific Hub” for the labelling and distribution of clinical supplies to all Asia Pacific countries. This hub would be Fisher Clinical Services Singapore. All IMP were sent directly to this facility, which would then handle all label printing, secondary packaging, ancillary supplies and comparator sourcing functions for clinical trials conducted in the Asia Pacific region. All the above services had provided the Sponsor with much flexibility. In addition, the capability to import pooled stock to Singapore and to label it at a later stage further accommodated the Sponsor’s increase in adaptive clinical trials in the region. In addition, as Fisher Clinical Services is an approved member of the importer of Clinical Trial Medicinal, the Sponsor could be exempt from paying 7% GST (Goods & Services Tax) on all supplies imported into Singapore for Clinical trial purposes. This represented significant savings for the Sponsor.
- Confidence in consistent and high quality standards of a cGMP facility
- Centralized inventory management
- Validated storage conditions for ambient and cold chain supplies
- Quick response to special trial requirements – late stage customization, Just In Time labelling
- High level of control over distribution of supplies maximizing cost and performance efficiencies
- Proactive regulatory support and guidance speeds up study timelines in the region
- Simplified contract and invoice demands on the Sponsor
- Dedicated staff ensures high level of attention to detail on all studies
On Going Monitoring
In order for this new Regional Hub Approach to work effectively it was important to clearly define roles and responsibilities of key functions – Account Management, Study Set-Up, Project Management, Warehouse Management and Transport Management. Dedicated Project Managers were solely designated to the Sponsor’s studies to oversee all aspects of its studies from start to finish. Logistics decisions are based on real-time and historical data on shipments and courier performance. This data-driven objectivity continues to drive optimized courier selection realizing cost and performance efficiencies.
Frequent monitoring of the defined Regional Hub Strategy ensures control, compliance and visibility of inventory at all times. The team continues to maximize On-Time In-Full delivery of supplies, reducing overall costs and mitigating risk across the supply chain.