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What is the difference between conducting a clinical trial in the US compared to EU?

Q&A with Bianca Horr, Clinical Project Manager, genae Germany

Q: What is the difference between conducting a clinical trial in the US compared to EU?

A: This really depends on several factors and needs to be discussed with the clients. You need to consider the following:

  • What kind of device is under investigation?
  • What is the goal of the study: is it pre-market, post-market or only observational?
  • What is the patient landscape?
  • What is the budget? When you perform studies in the US, it is usually more expensive.
  • What is the reimbursement climate for the device?
  • Are already competing devices commercially available in the selected countries?
  • Which European countries are expected to take part in this study?
  • Conducting the trial in Europe is associated with a variety of languages. Therefore you need translations of the IFU, the ICF and the Protocol summary.
  • In the different countries, you may have different requirements with regard to import, safety reporting and also for submission and approval timelines.

So these are just some of the items to take under consideration when choosing to perform a study in Europe or in the US.

Discover our other Q&A videos:
​​​​​​​•   What is the advantage of selecting a medical device CRO for your clinical trial?
​​​​​​​​​​​​​​​​​​​​​​​​• ​​​​​​​  What are the key documents or elements that a sponsor tends to forget when preparing a study?
• ​​​​​​​  What pricing should we consider for investigator / patient fees? ​​​​​​
​​​​​​​​​​​​​​• ​​​​​​​  Are your CRA’s genae employees or do you work with consultants?
​​​​​​​​​​​​​​​​​​​​​• ​​​​​​​  How can you leverage information of an already conducted trial?
​​​​​​​​​​​​​​• ​​​​​​​  How are your genae CRA’s trained?
​​​​​​​​​​​​​​• ​​​​​​​  How do you make sure patients come back for their follow-up?
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• ​​​​​​​  How can you speed up enrollment?
​​​​​​​• ​​​​​​​  How does genae work with third party vendors?
​​​​​​​• ​​​​​​​  Which factors can impact the duration of your study?

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