Safety Management/Monitoring Plan.
Creating the path to trial safety, through planning.
Our clinical safety consultants can advise you on the best way to set up the safety management of your trial, taking into consideration the study phase, indication, subject, other parties involved in the trial execution and budget.
Our safety management approach is described in your safety management/monitoring plan.
We can prepare and review your safety management plan, with all associated forms, including business contingency planning for Serious Adverse Event (SAE)/ Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting, to manage all your trial drug safety information.