More and more regulatory authorities are specifying that the sponsor of a clinical trial is legally responsible for the proper conduct of a clinical trial. Although certain responsibilities can be subcontracted, the authorities require that the sponsor undertakes a sufficient effort to properly audit the vendors prior to the selection of a vendor and during the clinical trial to ensure compliance with these regulations.
LUMIS International can arrange for the appropriate auditors to audit your company’s vendors in the EU in order to meet the specific requirements associated with the increasing tendency of the regulatory authorities to place responsibility upon the final sponsor.
When performing clinical trials in the European Union, it is important to understand the specific requirements that apply to data processing as required by the European Data Protection Act and the legislation resulting from its national implementation. Non-compliance can lead to fines and in some countries even to criminal sanctions.
LUMIS International can provide the right advice through our partners at Salvius Legal on how to ensure compliance with the current data protection legislation when performing a clinical trial in the EU.