Q&A with Thelma Bueno, Sr. Clinical Project Manager at genae Americas
Q: Are there any barriers to sites getting approved in a valve trial?
A: To receive approval to market a class II high-risk device in the United States, the manufacturer must demonstrate that the device is reasonably safe and effective; which as we all know, usually requires a prospective, adequately powered clinical trial involving hundreds of patients. So, sponsors need to ensure that their clinical trial is adequately powered.
Discover our other Q&A videos:
• How do you go about ensuring that a site is appropriate for a valve study?
• Are there any specific pieces of information you would include in a site feasibility survey for a valve trial?
• For valve studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
• What unique aspects of a valve subject population make enrollment/recruitment/retention particularly difficult?
• Are there procedures specific to the conduct of a valve trial that sponsors/principal investigators should be aware of?
• Is there anything in the design of a valve trial that you foresee as a source of difficulty when it comes to executing?
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