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Clinical trial supply logistics
– large European Biodesign company
Problem
A large European Biotech company wanted to run several worldwide clinical trials using the same drug. The client wanted to extract the maximum benefit, in terms of clinical studies, from extremely limited drug supplies further compounded by a short shelf life.
Approach
Internal CTS operating procedures were reviewed. Study protocols were reviewed to assess overall requirements including potential impacts. Particular care was paid to:
- Languages
- Regulatory requirements
- Import licences
- Length of time or weather configuration for shipment to the more obscure territories.
Deliverables
A new framework of internal CTS operating procedures was recommended and put in place. Eden Biodesign defined and documented the study supply requirements and produced an all encompassing planning document.
An Eden Biodesign consultant took responsibility for day-to-day project communication, both with regulatory affairs groups and CRO's regarding country specific requirements.
Forward and back translations were sourced and suitable contract packer identified; the labelling, packing and shipping to all destinations was managed; and Eden Biodesign staff helped train up internal resources.Benefits
The clinical trials proceeded as planned. Eden Biodesign delivered operating procedures and internal staff were trained in their use, providing a long-term solution.
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