Multiple Global Trials and Limited Product Availability Requires Innovative Solution
Our client, one of the world’s leading Biotech companies approached us with a need to find an innovative solution – how to service multiple global studies whilst not adversely affecting the limited inventory of available drug.
This biotech company, having worked with Fisher Clinical Services Horsham in the past, clearly vocalized their known foreseen challenges:
- Increase in volume of trials to be executed over a defined period of time
- Multiple protocols running in over 30 countries in all regions of the world
- Additional complexity of supporting inexperienced investigators
- Need to respond quickly to patient needs due to short enrolment period with limited availability of costly drug
- The prospect of high overage due to difficult to predict demand
Innovative Solution Needed
Through a global cross functional team founded on specialists from IT, Quality, Project Management, Engineering, Operations, Finance, and external Vendors, Fisher Clinical Services Clinical Services Horsham defined a new, quality assured global process that could be effectively rolled out across our network of strategically located GMP facilities across the globe. This new solution would have to be robust adhering to our GMP standards and to additional quality measures defined by our Quality Teams across the network.
This innovative solution would involve pooling supplies within the Fisher Clinical Services’ Facility Network with regional facilities set up to provide maximum flexibility of inventory to meet the needs of the study. It would allow labels at the study, component, and country level to be applied at the point of despatch before being shipped directly to the investigator.
Fisher Clinical Services identified the need to secure a mandate of support from the MHRA as these clinical supplies would be used for multiple protocols across 30+ countries. After a thorough analysis of this new approach and with approval from the MHRA secured, Fisher Clinical Services embarked on making significant investment in infrastructure and on leveraging our existing IT platform to accommodate the unique nuances of applying this new approach to managing inventory and executing despatch of clinical supplies in a short timeframe.
This unique solution has delivered a controlled process ingrained into Fisher Clinical Services systems that allows information normally controlled within a Production Order to be applied at point of despatch. Fisher Clinical Services Operational Teams across all facilities are trained to this new way of working.
- MHRA approved, system based solution with global coverage
- Maximum flexibility of high value and/or limited inventory IMP / Comparator
- Reduction of overage and the impact of a short shelf life
- Last minute decision making of when to commit inventory to a patient
- Rapid turnaround of shipment requests direct to site
Fisher Clinical Services Horsham ensured security of supply for 10 different drugs used across 43 different protocols. In addition, Fisher Clinical Services Horsham ensured that each trial met the regulatory requirements of all 32 countries involved, with the capability of turning around a shipment request in 3 working days to accommodate patient schedules. Over time the Sponsor reduced overage by a further 150% from an initial assessment of 70%.
Fisher Clinical Services can now apply this flexible solution to a variety of study designs servicing the innovative solutions being requested by this biotech company and indeed by other Biotech and Pharmaceutical companies facing similar challenges to those outlined above.