Q&A with An Goethals, Director Clinical Research, genae Belgium
Q: What is the advantage of selecting a medical device CRO for your clinical trial?
A: Often, people don’t realise, but Medical Device trials have to comply to different regulations than pharmaceutical studies. Therefore it's very important to work with the right people who know the ins- and outs of this.
As a medical device CRO, having done over 400 studies mainly with class II and III devices, we are very acquainted with the regulations and requirements for Medical Devices studies. This gives us a broad knowledge and expertise in the medical device clinical world which helps us to facilitate the needs of Medical Device companies.
Discover our other Q&A videos:
• What pricing should we consider for investigator / patient fees?
• What are the key documents or elements that a sponsor tends to forget when preparing a study?
• Are your CRA’s genae employees or do you work with consultants?
• How can you leverage information of an already conducted trial?
• How are your genae CRA’s trained?
• How does genae work with third party vendors?
• How do you make sure patients come back for their follow-up?
• How can you speed up enrollment?
• Which factors can impact the duration of your study?
• What is the difference between conducting a clinical trial in the US compared to EU?
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