Pharmacovigilance

AbCRO provides exclusive safety services which include, but are not limited to: case review and evaluation, case coding, e-submission of expedited reports to EMEA and Regulatory authorities trough EudraVigilance system; preparation and submission of periodic safety reports across EU and non EU countries in Europe; managing of submissions of expedited and periodic safety reports in non-EU countries; medical monitoring activities: monitoring the safety of study participants throughout the trial, identifying of safety signals and safety trends, ongoing risk/benefit assessment, 24/7 physician coverage; providing of Safety Trainings to all responsible personnel; Other project specific safety related activities as agreed.