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E9(R1) Addendum: Estimands & Sensitivity Analysis in Medical Device Trials
E9(R1) Addendum: Estimands & Sensitivity Analysis in Medical Device Trials
brooke attixMay 1, 2025
E9 Statistical Principles for Clinical Trials: The Foundation of Regulatory Success
E9 Statistical Principles for Clinical Trials: The Foundation of Regulatory Success
brooke attixApril 15, 2025
What is MDR? Understanding Medical Device Regulation Compliance
What is MDR? Understanding Medical Device Regulation Compliance
brooke attixJuly 15, 2024
The Critical Role of Radiographic Data in Medical Device Clinical Trials
The Critical Role of Radiographic Data in Medical Device Clinical Trials
brooke attixJuly 1, 2024
The Role of DMCs
The Role of DMCs
brooke attixJune 15, 2024
Primary vs Secondary vs Exploratory: Building the Right Endpoint Hierarchy for FDA Success
Primary vs Secondary vs Exploratory: Building the Right Endpoint Hierarchy for FDA Success
brooke attixJune 1, 2024
Multiple Endpoints in Clinical Trials: Why Medical Device Manufacturers Can’t Afford to Ignore Multiplicity
Multiple Endpoints in Clinical Trials: Why Medical Device Manufacturers Can’t Afford to Ignore Multiplicity
brooke attixMay 15, 2024
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