Q&A with Patrick McCabe, Sr. Clinical Project Manager at genae Americas
Q: Are there any barriers to sites getting approved in a cardiovascular trial?
A: The barriers can be different for every study and every country that you plan to conduct the trial in. Again, using local IRBs can lead to longer review times and delayed recruitment start times. Some sites are better than others. Each country may have different competent authority requirements.
You’ll find yourself jumping through hoops in one country while their neighboring country approves the study without complication. We have experience working in over 43 countries and have been exposed to, and learned from, these complications. Helping device sponsors choose countries and sites that can speed up first patient in, that is something we take pride in.
Discover our other Q&A videos:
• How do you go about ensuring that a site is appropriate for a cardiovascular study?
• Are there any specific pieces of information you would include in a site feasibility survey for a cardiovascular trial?
• For cardiovascular studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
• What unique aspects of a cardiovascular subject population make enrollment/recruitment/retention particularly difficult?
• Are there procedures specific to the conduct of a cardiovascular trial that sponsors/principal investigators should be aware of?
• Is there anything in the design of a cardiovascular trial that you foresee as a source of difficulty when it comes to executing?
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