PK, statistics & Data management Unit
Data management staff are responsible for:
management and collection of data for all studies which are performed at FRC including bioequivalence, biowaiver, and stability studies for writing the final study report.
Performing Pharmacokinetic calculations and statistical analysis for bioequivalence studies using the latest version of Winnonlin licensed and validated software.
Performing sample size calculations and randomization plan generation for bioequivalence studies using R statistical program, an open-source software.
Preparation of all folders related to the studies (clinical or/and analytical raw data) for archiving process.