THROUGH THE HERO FRAMEWORK™ WE OFFER A WEALTH OF EXPERIENCE FOR GATHERING AND ANALYZING PATIENT INSIGHTS EFFECTIVELY
Under no circumstances will we compromise patients’ safety in any study. Patients’ risk-benefit balance will be considered in certain scenarios where ethics committee opinion is crucial.
We will work to set up studies in a proper manner, minimizing risk for clients by ensuring that study results can be published and will not be rejected from regulatory submissions.
Regulators evaluate risk from a wider societal and health economics perspective in addition to patient perspective. For example, they may withdraw a product because of a safety concern, yet patients may still prefer to take it due to few or no alternatives. In this paper, we will offer you guidance, as enforcement actions will be stricter on high risk studies, but prior IRB/EC approval and relevant regulatory notification will be sufficient for low risk studies.
In this paper, all levels of risks are considered.
Written by Dr. Jessica Santos, Global Compliance and Quality Director at Kantar Health, she is a recognized leader in all healthcare research regulation. She is primarily responsible for providing oversight and support across Kantar Health’s global offices in the areas of regulation, interaction with clients, suppliers and others within Kantar Health, Kantar and WPP.