Q&A with Mieke Roelants, Director Regulatory Affairs & Market Access, genae Belgium
Q: Which country should I go to for my clinical trial?
A: This is really an important question because the evaluation on which countries you want to select for your clinical investigation will have a big impact on the timelines and the overall success of your clinical study. Unfortunately, the answer is not a one-fits-all solution and it depends on many different factors.
What is the regulatory landscape in that particular country? Is your device CE-marked? What kind of reimbursement are you looking for? How is the healthcare situation in that particular country? Who are the Key Opinion Leaders you want to work with? How well experienced are they? How committed are they to boost your enrollment?
All these different factors need to be taken into account. genae can help you of course with assessing these factors and can make sure that the countries that you select really fit your clinical investigation.
Discover our other Q&A videos:
• Which medical devices fall under the EU MDR scope?
• By when do I need to update the Clinical Evaluation Report (CER)?
• How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
• Why is it important for manufacturers to focus on the health economics of their device?
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