Module232025

09/05/2025

Role of M&S in PIPs/iPSPs

Need to minimize number of subjects enrolledin pediatricclinicaltrialsand the need to maximize the usefulnessofthe data obtainedwhileensuringthat the trialsare feasible, robust and interpretable

It is essential to have M&S input on the PIPs and iPSPs as soon as posible to serve as guidance for the overall strategy

The Organisation for Professionals in Regulatory Affairs

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Case examples

Blinded data and altered values

The Organisation for Professionals in Regulatory Affairs

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