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Contributors: Nicolas Borenstein (DVM, MsC, PhD), Jennifer Gordon, Michael Sweet Don't ask "Can this model work?" Ask "Is this the optimal preclinical model for regulatory success?" When your breakthrough, truly novel or generational new medical...
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Behind many successful medical devices are design and engineering firms that provide the technical expertise, regulatory knowledge, and development...
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Contributors: Naghmeh Nouri, Nick Benedetto The Art of the Specific Question for FDA Pre-Submission Guidance and Human Factors FDA pre-submission...
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Some ventures launch on clever tech alone. Most of those fade. The ones that stick seem to orbit three ideas that came up again and again when Dr...
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Institutions and enterprises around the world are pushing the boundaries of medical innovation by applying advanced robotic technologies to address...
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The investigational model considered the use of the EXENT® GAM Assay from the Binding Site, part of Thermo Fisher Scientific. This is a mass...
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The clinical research landscape is rapidly evolving, placing increased importance on robust and compliant clinical data management services (CDMS)....
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Prediction: In 10 years, clinical trials will be nearly paperless. And clinical trial historians will note that the coronavirus pandemic was the...
