What the GDPR means for US Sponsors of Clinical Trials in the EU and in the UK

Why you most likely have to appoint an EU and/or UK data protection representative in order to avoid sanctions under the GDPR

Does the GDPR apply to your clinical trials in the EU and/or in the UK?

  • Are you a US-based sponsor with no establishment in the EU and/or the UK? 
  • Do you conduct clinical trials in the EU and/or in the UK?

If you answered yes to both of these questions, then you most likely fall under the scope of the GDPR and have to appoint an EU-based and/or a UK-based representative for GDPR purposes.

GDPR and Clinical Trials: Key considerations for US Sponsors

The GDPR has changed the way personal data is handled in clinical trials. Find out what you need to know as a US sponsor about the impact of the GDPR for your clinical trials in the EU and in the UK. There are currently approximately 400,000 clinical trial studies...

Download our White Paper on The GDPR and US Sponsors of Clinical Trials in the EU & the UK

How can EDPO help you?

As your GDPR data protection Representative, EDPO will provide you with the following services (which are all included in our annual fees):

  • The handling of an unlimited number of requests from individuals (data subjects) and from data protection authorities in the EU and/or the UK
  • Assistance with the handling of an unlimited number of data breach notifications to the data protection authorities in the EU and/or the UK
  • The storage of a copy of your Record of processing activities on a platform that has the highest security levels in Europe (ISO27001)
  • Translation of requests and replies (from the initial language into English, and from English back to the initial language)
  • The right to use EDPO’s contact details and logo on your website and on other company material
  • The granting of the EDPO Compliance Certificate
  • Alerts regarding relevant GDPR-related news and developments

Get your Compliance Certificate

  • Lets customers know that your company is accountable and that your compliance with Article 27 of the GDPR is verifiable
  • Creates trust and provides security
  • Informs your business partners that your company complies with the EU’s data protection standards and allows for greater business opportunities
  • Provides your company with a competitive advantage
  • Reduces risks of heavy sanctions that can reach up to EU 20 million or 4% of global turnover, whichever is highest
  • Guarantees authenticity by use of the Smart Certificate™ technology

EDPO helps your US business grow while

protecting EU and UK customers