- Compliance with EU Data Protection Regulation
- Representation of sponsor’s obligations
According to the General Data Protection Regulation GDPR EU 2016/679 Art. 27 all Non-EU registered companies must appoint an EU Data Representative for their clinical trial. You are required to comply with the GDPR when processing personal data of patients within the EU and when transferring personal data from the EU to a third country.
Compliance with GDPR is essential for performing clinical trials in the EU. Non-compliance leads to warnings and fines and in some countries even to criminal sanctions.
What we can do for you
- Act as your primary contact person for the supervisory authorities and clinical trial participants, related to data protection issues
- Oversee data processing activities and all data transfers within a clinical trial
- Provide guidance to adhere with the requirements of the GDPR
Our expertise, your benefit
Lumis International has a network of data protection officers and lawyers specialised in data protection. They have long-standing expertise in developing the needed processes and agreements to:
- Be compliant with EU data protection requirements
- Be represented according to GDPR article 27
- Get assistance in the implementation of compliance requirements