- Compliance with EU General Data Protection Regulation (GDPR)
- Compliance with UK General Data Protection Regulation (GDPR)
- 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 a Data Representative based in Europe for their clinical trial.
According to Article 27 of the UK-GDPR, non-UK based companies must appoint a Data Representative based in the UK for their clinical trial. This service will be provided by Lumis International Limited.
You are required to comply with the GDPR when processing personal data of patients within the EU and UK and when transferring personal data from the EU or UK to a third country.
Compliance with GDPR is essential for performing clinical trials in the EU and UK. Non-compliance leads to warnings and fines and in some countries even to criminal sanctions.
What we can do for you
Our expertise, your benefit
Lumis International has a network of data protection officers and lawyers specialised in data protection. They will apply their long-standing expertise and knowledge to help ensure that you are:
- Compliant with EU and UK data protection requirements
- Represented according to EU GDPR article 27 and UK GDPR article 27
- Fully supported in the implementation of compliance requirements