You will need a legal representative in the EEA and non-EEA countries in order to conduct clinical research. We can take on that role. This will require our involvement in audits and vendor selection as well as oversight of processes such as IMP supply. We also would be involved in regulatory inspection preparation, hosting and responses.
Oversight of clinical research is not just a requirement of the Legal Representative, as ICH GCP and European Legislation make it clear that the Sponsor retains overall responsibility. We will work with you to ensure that you can demonstrate oversight of all the European processes for which you are responsible as Sponsor.