With the implementation of the Clinical Trial Regulation (CTR)(No 536/2014), the European Commission hopes to realize its ambition to create an even more favorable environment to conduct clinical trials within the EU. The CTR governs all interventional clinical trials conducted in the EU with medicinal products for human use.
According to Article 74 of the CTR, Sponsors of a clinical trial not based in the EU are required to appoint a company established within the EU to act as their legal representative. The legal representative ensures compliance with the Sponsor’s obligations under EU CTR and, amongst other obligations, notifies the Sponsor immediately if he becomes aware of any non-compliances with the EU CTR.
Being a full-service CRO with its headquarters in France, ExperTrials is qualified to serve as your Legal Representative in Europe.
Although the UK is no longer part of the EU’s single market and Customs Union since 1st January 2021, the UK has adopted the requirements of the EU CTR and accepts a Legal Representative of a non-European Sponsor company if it is based within the EU.
The general process for legal representation in the EU can be summarised as follows :
Personal data privacy has been considerably reinforced with the release of the EU Regulation 2016/679 on the protection of natural persons, and this so-called General Data Protection Regulation (GDPR) came into effect on 25 May 2018.
If your clinical trial collects personal data from citizens within the European Economic Area (EEA), then this GDPR also applies to your study. Beware that the GDPR does not distinguish between personal data of patients, investigators and other study team members, or even CRO employees.
The three main parties involved in GDPR are described as below:
1 – Data Controller (= the Sponsor)
Companies sponsoring the data collection in view of automated processing (paper or electronic), e.g. Pharma or Biotech companies
2 – Data Processor (= the Clinical Research Organization)
Companies processing data provided by others, or collecting data on behalf of others e.g. CROs, software vendors, data hosting companies, clinical sites
3 – Data Protection Authority (the DPA)
Country-specific Authorities controlling data protection and legal application
Do not get confused with the roles of the Data Protection Representative and the Legal Representative of the Sponsor in the EU. There is a clear distinction between these two functions encountered in the context of clinical studies. The designation of a Data Protection Representative is an obligation that comes from the General Data Protection Regulation while that of a Legal Representative is an obligation imposed by the Clinical Trials Regulation.
Article 27 of the EU GDPR requires that non-EU companies appoint a Data Protection Representative in the EU if they intend to process the personal data of individuals in the EU.
Every clinical study you conduct has its unique features, and it is paramount for you to know in which way the GDPR applies to your specific study, taking into account its geographical and material scopes, and ensuring that all relevant GDPR requirements are fulfilled not only by your company, but also by your European contractors and vendors.
With our GDPR experts, ExperTrials will help you find your way through the GDPR jungle.