Pharmacovigilance

SFS is aligned and focused in the patient safety at the very first step and independently of the clinical trial status. The most important base is the correct management of a pharmacovigilance system since the beginning, to guarantee the safety of the subjects in any clinical trial.

We manage
and control the adverse events.

We code
drugs and adverse events using international dictionaries.

We prepare
and deliver notification to regulatory agencies and ethical committees.

We help
with the signal detection using bibliography and last articles.

We reconciliate
adverse events with CRF database to create a final report.

We prepare
SAEs, SUSARs and all event reports to local authorities.