Nowadays, the existing and new biopharmaceutical products landscape includes the understanding and management of their quality and potential risks. Operating with the right expertise, process and systems, MEDONE Research ensures an efficient and cost effective way, by providingcomprehensive and flexible pharmacovigilance and safety monitoring serviceswhere the patient safety has always the highest priority.
From preclinical studies through post-approval stages, our company grants with confidence fully integrated pharmacovigilance services, transforming them into a competitive convenience.
Medone’s Team provides :
- a Safety monitoring plan and Medical assessments of SAEs
- Comprehensive reporting : FDA periodic reports , Annual Safety Report (ASR) and PSURs (periodic safety update reports), Individual Case Safety Reports processing for Serious Adverse Events (SAEs)
Medone Research can assist you by offering the complete portfolio of pharmacovigilance and risk management services through the entire lifecycle of a product:
