Safety Management Plan

Our clinical safety consultants can advise on the best way to set up the safety management of your clinical trial or study, taking into consideration the study phase, indication, subject, clinical campaign, e.g.,:

• If your study is a ‘sub-protocol’ of a complex clinical trial and characterized by extensive prospective adaptations such as planned additions of new Investigational Medicinal Products (IMPs)
• New target populations, other parties or vendors involved in the trial execution, or
• If your study is a voluntary PASS or an imposed one, which are normally warranted under exceptional circumstances (for rare diseases).

In close partnership with you, we can co-develop 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 your trial drug safety information.