One of the top major pharmaceutical companies had a high number of studies already in progress in the Asia-Pacific region. The sponsor’s required many more studies in this region, but had concerns about its current distribution approach. The Sponsor recognised the need to review its distribution model for existing and planned studies in an effort to realise efficiencies in cost and performance.
Country specific affiliates
Traditionally, all packaging and labelling functions were carried out in North American or European facilities before being 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 good manufacturing practices (GMP) / good development practices (GDP) standards. In addition, this traditional model presented other challenges:
- High inventory overage and poor inventory visibility
- Investigational medicinal product (IMP) wastage
- Non-refundable tax and duty payments upfront
- Additional fragmented costs, such as emergency deliveries
- Exposure to risk of pilferage, order delivery accuracy, and timeliness of shipments
- Varying destruction costs and processes for each country
Analysis
Historically, there were many parties involved in managing the Asia-Pacific trials. 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 realising 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 was ‘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 of the 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% goods and services tax (GST) on all supplies imported into Singapore for clinical trial purposes. This represented significant savings for the sponsor.
Benefits:
- Confidence in consistent and high-quality standards of a current good manufacturing practice (cGMP) facility
- Centralised inventory management
- Validated storage conditions for ambient and cold chain supplies
- Quick response to special trial requirements, late stage customisation, 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
Ongoing 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 maximise on-time in-full delivery of supplies, reducing overall costs and mitigating risk across the supply chain.