In France, the process for submission and approval by the Ethics Committee and the
Competent Authority is well defined. However, the requirements of other stakeholders
must also be met before your study can start. And since the publication of the “Sunshine
Act” decree in May 2013, the process for contracting with the investigational sites became
more complex. .
Here, Martine Roggemans shares her knowledge of clinical research in France, describing both the landscape for clinical research and introducing the regulatory processes involved.