MDSTAT Consulting

Clinical studies for pharmaceutical and biotech laboratories

When to call a biostatistician

Pre-clinical Phase, Phase I & II

Whether you need to justify and optimize the sample size, define the best dose for the treatment, find the adequate criterion of effectiveness, there are plenty of reasons to call on a professional in clinical trial's methodology.

The biostatistician’s support guides you whether you need help with the choice of experimental design or to understand the statistical results (to acknowledge better information than just the “p-value”).

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Phase III & submissions

In order to confirm the efficiency of the new drug, one or two pivotal studies are carried on, in the framework of strict and constantly evolving statistical best practices.

The choices that will be made at the outset will be crucial when assessing the case. With the help of a biostatistician throughout the process to supervise the work carried out by your CROs , you will benefit from resources with history as well as an overview in regards to your developing project.

MDSTAT Consulting will guide you in the best possible way through your regulatory proceedings, alongside your team.

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