Q&A with Rebecca Hinton, Clinical Project & Safety Manager at genae Americas
Q: How do you go about ensuring that a site is appropriate for a neurology study?
A: First and foremost, we look at the qualifications of the study staff. Does the site have board certified neurologists or neurosurgeons on staff? Do those team members have adequate surgical experience?
Second, we look at the patient population. Neurological device studies can often be challenging studies to recruit for in the general population, so we look for sites who see these patients in their regular medical practice.
We also consider the specifics of the study. If a study involves emergency neurological treatment, it will be important for the site to have 24/7 neurosurgical capability, and a neuro-intensive care unit.
Discover our other Q&A videos:
• Are there any specific pieces of information you would include in a site feasibility survey for a neurology trial?
• Are there any barriers to sites getting approved in a neurology trial?
• For neurology studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
• What unique aspects of a neurology subject population make enrollment/recruitment/retention particularly difficult?
• Are there procedures specific to the conduct of a neurology trial that sponsors/principal investigators should be aware of?
• Is there anything in the design of a neurology trial that you foresee as a source of difficulty when it comes to executing?
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