Q&A with Liesbet Menten, Director People Operations at genae
Q: Are your CRA’s genae employees or do you work with consultants?
A: 95% of the US work and about 85% of the work in Europe is currently done by our own genae employees out of our offices in New York, San Francisco, Cleveland, Frankfurt, Zurich or Antwerp. Where needed, due to language or regulatory requirements, we work closely together with consultants.
A lot of these consultants have worked for many yearswith genae. Therefore we can offer our sponsors a native speaking CRA in those countries where we do not master the language ourselves. Our consultants are fully trained on all our genae SOPs and are closely followed up by the genae Clinical Project Managers on study level, in the same way as how they manage our own genae CRAs.
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• When should you involve the FDA in your clinical trial planning?
• How can you leverage information of an already conducted trial?
• How are your genae CRA’s trained?
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