HOTLINE 24/7/365 UK: +44 (0) 1483 212150

Statistical Analysis

For most Clinical plans or large post-marketing observational studies there is a need to utilize statistical software packages in order to know how many patients are required in a study in order to demonstrate product equivalence, superiority, statistically significant differences and confidence levels of those differences. Above the software packages themselves are the statisticians who know what types of studies require which type of analyses in order that the correct statistical approach has been applied.

Such a person is vital either in scientific pre-discussions with Regulatory Agencies concerning the type of analysis or understanding of the size of patient recruitment to demonstrate what the Regulators would like to see. Their expertise is critical to the success of the approval itself.

PharSafer® Tweets

Key considerations from the questions and answers include safety reporting, Eudravigilance, EudraCT, PSUR Repositor… t.co/wk5hfKkJQw

Read on Twitter...

The European Medicines Agency has published their latest questions and answers for stakeholders, regarding the impl… t.co/YYox8pKBbf

Read on Twitter...

In addition to issuing a reminder for those wishing to speak in the meeting, to register their interest by 27th Nov… t.co/k0S2I3cT8b

Read on Twitter...