The European Parliament has recently approved the General Data Protection Regulation (GDPR). Its implementation and adoption by all the Member States over the next two years will challenge both users and managers of clinical data. Training and strategic counselling will be key to succeed for both private and public institutions as they move to comply with the new legislation, minimizing liabilities while controlling costs to update existing infrastructures. Lynkeus’ specialised compliance advisory is there to support how to effectively navigate this key new Regulation.