Outsourcing Statistics


Biostatistics Methodology for Regulatory Submissions Event on 2017-07-04 09:00:00 INTRODUCTION The publication in 1998 of ICH E9 guidance on Statistical Principles in Clinical Trials brought a degree of clarity and harmonization to the statistical requirements of the major regulatory authorities. Since that time the FDA and EMA have issued a […]

Biostatistics Methodology for Regulatory Submissions