How to supply clinical trials with Drug-Device Combinations?
Supplying clinical trials with drug & device combinations such as inhalers or auto-injectors adds a level of complexity. In addition to supplying and resupplying the drug, clinical supply managers must ensure that devices are accounted for as well. Some countries, such as Russia and Turkey, limit the number of devices that can be imported per number of patients expected to enrol in a trial.
In this audio recording, our team chats about:
- Recommendations for combo drug & device kit design, packaging, and blinding
- The regulatory & logistical challenges that sponsors face globally
- Import & export concerns with combo drug & device kits