Q&A with Rebecca Hinton, Clinical Project & Safety Manager at genae Americas
Q: Is there anything in the design of a neurology trial that you foresee as a source of difficulty when it comes to executing?
A: Study sponsors often want to be present for the first device implantation that occurs at a site to review the quality of the neurological procedure, and help troubleshoot potential problems. This requires close communication and flexibility on the sponsor’s behalf.
However, sometimes site’s privacy policies can prevent this type of oversight. In such a case, alternative quality control methods, such as providing a de-identified video recording, can be employed.
Discover our other Q&A videos:
• How do you go about ensuring that a site is appropriate for a neurology study?
• 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?
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