Device / Drug Combo
Device/Drug trials are like the fraternal twins of clinical trials. While some agencies globally have clear guidelines for device and drug trials, the regulations haven’t kept up with the advances of the combination products in many countries, complicating the regulatory pathway.
The device itself generally carries additional logistical considerations:
- Is the proposed device experimental or non-experimental
- Who is providing the device
- If the device is approved does it carry the appropriate marking for import
- At the end of the study what happens to the device
- Who provides the device training (set-up, use, cleaning)
Our team has experience across multiple countries with these unique trials in our core competencies: CNS, Infectious Disease, and Oncology.