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.

What Is A RoPA? Record Of Processing Activities Under Article 30 GDPR (Including Non-EU Companies)

Article 30 GDPR explained for EU and non-EU organisationsA record of processing activities (often shortened to RoPA) is not a “nice to have”. It is a core GDPR accountability requirement under Article 30 GDPR....

AI Act: Are you ready?

The AI Act is here. Are you truly compliant? The new European Regulation on artificial intelligence, the AI Act, is redefining how AI may be developed, deployed, and governed across the EU. If your company...

Understanding GDPR: What You Need to Know in 2025

In 2018, the European Commission introduced the General Data Protection Regulation (GDPR). It shook the world because it applied both to European businesses and to any organization that processes the data of...

5 GDPR mistakes US companies make in 2025 – and how to avoid them

The General Data Protection Regulation (GDPR) continues to apply to many US companies in 2025, even if they do not have a physical presence in the European Union. Despite years of guidance and enforcement, the...

EDPO at the 38th Privacy Laws & Business Conference in Cambridge

From AI governance to legal design: key takeaways from Europe’s leading privacy event EDPO recently took part in the 38th International Conference hosted by Privacy Laws & Business, set against the...

IAPP Intensive – London, UK – March 2023

DAY 1 The IAPP - International Association of Privacy Professionals Data Protection Intensive: UK 2023 kicked off this Wednesday with John Edwards (Information Commissioner's Office’s Commissioner)’s engaging...

UK GDPR and EU GDPR – Differences and Similarities

What are the main differences between UK GDPR and EU GDPR? The UK GDPR is largely based on the EU GDPR but adapted for the UK. The main differences are: it applies to data subjects who are in the UK, instead of...

ISO 27001 added value

ISO 27001: Security You Can Rely On At EDPO, we provide representative services under Article 27 of the GDPR and other digital regulations. To support this role, and to ensure the highest standards of security...

EU GDPR Quick Guide to GDPR Fines and Sanctions

The EU’s General Data Protection Regulation (GDPR) was one of the first privacy laws to compel broad organizational compliance, largely because the cost of non-compliance can be extremely high. Under the GDPR,...

EDPO participated in the Belgian Economic Mission to Japan – Dec. 2022

EDPO is thrilled to have been part of the Belgian Economic Mission to Japan with HRH Princess Astrid of Belgium last week - and what a crazy week it was! We had the opportunity to catch up with some of our...

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