The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks.
In this installment of Risk Management 360, we look at clinical trials. This article discusses how products liability that arises from a clinical trial can be mitigated with the right practices and...
June 17, 2020
This session presenters, Dianne Bourque and Benjamin Zegarelli from Mintz, will explore the widespread disruptions the crisis is posing to clinical trials for life sciences companies and to research...
Q: Can you provide us with some background on Biomedic-Insure? Frédérique Roumengous: Biomedic-Insure is an insurance brokerage company that procures clinical trials liability insurance for medical...
Logistical problems and financial pressures prompt many medical technology and life sciences companies to sponsor human clinical trials outside the borders of the United States. As important as the...
Abstract: Clinical trials—medical research studies involving people—play an essential role in the advancement of medical science and technology. The information obtained from clinical trials is...
Excerpted from the Journal for Clinical Studies, September 2009. As the number of trials being conducted in multiple countries continues to increase, sponsors must insure themselves against product...
Using employees as participants in a clinical trial is one solution for keeping trials on schedule. However, their participation and recruitment is fraught with the potential for inappropriate...
Food and Drug Administration (“FDA”) regulations establish the minimum requirements for all informed consent forms.