COLTRIALS is committed to participant safety from the beginning of their participation in the clinical trial, through the detection, evaluation, analysis, reporting and follow-up of adverse events, in compliance with current regulatory requirements.
The management of serious and non-serious adverse events during the clinical trial.
Timely reporting and evaluation of SAEs and non-serious adverse events presented in the study.
In the analysis of the causality of the serious and non-serious adverse event of the study