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Which factors can impact the duration of your study?

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

Q: Which factors can impact the duration of your study?

A: The duration of the study mainly depends on the type of the device you will investigate and in addition on the typical follow up of such a patient population.

For instance, when you’re dealing with an implantable device, the follow up period within the study will be longer than for a device which enters the body only for the treatment. Further impact on the study duration can be the amount of sites and the number of patients to be enrolled.

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

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