Airport security versus clinical trial monitoring

Airport security versus clinical trial risk management What does taking off your shoes and belt in the airport have in common with risk assessment in COVID-19 clinical trials? Today we talk about the drawbacks of traditional clinical trials risk assessment for COVID-19. The notion of fixed risks determined at the beginning of the project is …

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medical device clinical trials - remote monitoring

Why the CRO model for drug and device trials is broken and how to fix it

Who said: ‘If you are not part of the solution, you must be part of the problem’? This appears to be a misquotation of Eldridge Cleaver  author of the 1968 book “Soul on Ice” and early leader of the Black Panthers. The correct (full) quote is: ‘There is no more neutrality in the world. You either …

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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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