Data Representative

  • 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

  • Provide data representation services for clinical trials conducted in Europe

  • Provide data representation services for clinical trials conducted in the United Kingdom

  • 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 EU GDPR and UK GDPR

Not sure what a specific regulation says or want to know more about the meaning behind a certain term? Visit our glossary.

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

Contact our experts to find out more!

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    We look forward to being your data representative!

    Andrés Aguilar Caro. Proposal Manager, Lumis International GmbH

    Andrés Aguilar Caro

    Senior Proposal and Contract Manager

    Phone: +49 30 235911-599

    We look forward to helping you find your best fit in outsourcing your clinical trials!

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