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.
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