The protection of personal data in clinical trials is a major concern considering for instance the health data of patients. In the European Union this was strongly enforced on 25th May 2018 as the General Data Protection Regulation (GDPR) came into effect. Consequently, this affects Non-EU sponsors since they equally need to ensure full compliance with this regulation when conducting clinical trials in the EU. To ensure the enforcement of the GDPR, sponsors are therefore required to appoint an EU Data Protection Representative. We at GCP-Service, can offer you this representation ensuring your full compliance contributing to a smooth study conduct.
The GDPR affects your clinical trial in many ways, such as proper handling & reporting of data breaches, secure data transfer to 3rd countries, dealing with sensitive data processors, appropriate training of your study team and much more. Failing to meet this regulation often leads to unnecessary study delays. We for example often observe that submission procedures are prolonged as informed consent forms lack to meet the GDPR leading to a delayed study kick off.
However, our experienced Representative team can support you in meeting the various challenges set out by the GDPR. Our experts aim to increase your transparency and ensure that all regulatory requirements are met. We further resolve any uprising data protection issues throughout the study conduct. Among other things our service therefore includes the following:
- effective consultancy
- coverage of the entire European Union
- main contact point to supervisory authorities
- effective handling of data breaches
- preparation and review of GDPR compliant study documentation / submission dossiers
Our EU Data Protection Representative service can further be offered in combination with our Legal Representative for drug studies (acc. EU Regulation 536/2014) and Authorized Representative for medical device studies (EU Regulation 2017/745).
If you are in need of representation services or require some advice, we are happy to support you.
Please click here to get in touch with us.
Benjamin Tsiflidis (btsiflidis@gcp-service.com)
Phone: +49 (0)421 89 67 66 15
