How are your genae CRA’s trained?

Q&A with Liesbet Menten, CRA Manager at genae

Q: How are your genae CRA’s trained?

A: At start, new genae CRA’s are trained on all required regulations & genae SOPs and get familiar with all teams and processes within genae. They will observe at least 3  monitoring visits at site. Thereafter, a quality and effectiveness assessment is conducted before we can have our CRA's monitor independently.

Also, for the other types of visits, meaning the selection, initiation or the close out visit, we have a similar process of observing & assessment. We also organize personal development trainings and on a regular basis, we  conduct quality assessments at site.

When applicable, CRA's also receive a Cath lab training. All these training opportunities are set up to ensure a high quality and a consistent way of working for all our genae CRA's.

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​​​​​​​​​​​​​​• ​​​​​​​  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?
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• ​​​​​​​  How does genae work with third party vendors?
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​​​​​​​​​​​​​​• ​​​​​​​  How do you make sure patients come back for their follow-up?
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• ​​​​​​​  How can you speed up enrollment?
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​​​​​​​• ​​​​​​​  Which factors can impact the duration of your study?
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​​​​​​​• ​​​​​​​  What is the difference between conducting a clinical trial in the US compared to EU?

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