ICH GCP and EU Regulations impact on clinical trial monitoring

October 2015:  EU standards bodies are so far behind the curve that they now emphasize CSV (which been around since 1995 or so and formally documented in 2005 see Common Format and MIME Type for Comma-Separated Values (CSV) Files) as an indication of increasing computerization of studies: New emphasis on CSV expectations, as aspects of medical device …

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You can DIY a chair from IKEA. You cannot DIY your medical device clinical trial

  Jenya Konikov-Rozenman Jenya is a co-founder and VP Clinical at Flaskdata.io. Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads FlaskData.io customer operations with super-human devotion to customer delivery. Jenya has 2 children …

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