Legal and GDPR Representation
According to the EU Directive for Clinical Trials, Sponsors who do not have a legal residence in European Union or Switzerland must have a legal representative in order to conduct clinical trials.
Biomapas’ Legal and GDPR representation services cover, whilst not limited to:
- Interaction with the Competent Authorities and the Ethics Committees as the legal representative of the Sponsor;
- Assurance of smooth and timely communication with the professional bodies;
- Collection and storage of all Clinical Trial related information and documentation;
- Implementation of the Competent Authority decisions related to the Clinical Trial.