Q&A with Thelma Bueno, Sr. Clinical Project Manager at genae Americas
Q: How do you go about ensuring that a site is appropriate for a valve study?
A: Before approaching a site, it is important to understand not only their experience with implanting valves, but also their clinical research experience. It is also vital to understand the site’s access to the study population, the principal investigator and sub-investigator’s experience with similar types of procedures, and any previous experience working with the site.
Discover our other Q&A videos:
• Are there any specific pieces of information you would include in a site feasibility survey for a valve trial?
• Are there any barriers to sites getting approved in 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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