Patient safety is a top priority. Our Safety team works closely with Sponsors, sites, and regulators to effectively manage safety cases and assure compliance with all relevant reporting requirements.
Services include:
(but not limited to):
Prepare safety monitoring plan.
Report, manage and review Serious Adverse Events (SAE)/Adverse Drug Reaction(ADR), including case processing, narrative writing, Lab and diagnostics test review, and medical review.
Interact with Data Safety Monitoring Boards (DSMB).