What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.
What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.
The European Medicines Agency (EMA) has now published its third version of the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic. This guidance addresses the need for sponsors to change the execution of clinical trials during the global COVID-19 pandemic response.
Our process starts from the RFP stage. We usually send a feasibility questionnaire to the site prior to the study award, to get an in-depth assessment of feasibility at the RFP stage.