Accelerating Innovation in Structural Heart Care: Bioforum’s Role in Pi-Cardia’s FDA Journey Bioforum is proud to have supported Pi-Cardia in securing FDA clearance for ShortCut™—a first-of-its-kind solution in structural heart care. This collaboration demonstrates the value of expert data management and regulatory strategy in accelerating life-saving medical innovations. ShortCut™: Transforming Valve-in-Valve ProceduresPi-Cardia’s ShortCut™ is the …
Sample size is a quantity of immense strategic and ethical importance in treatment development. It is therefore surprising how many misconceptions there are among clinicians and statisticians regarding this topic. There are two parameters directly related to calculation of sample size: power and treatment effect. Let us first define the power of the trial. Power …
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