DLRC Pharma Services - Your representative for EU clinical trials
For sponsors based outside the EU, DLRC Pharma Services can act as the EU Legal Representative for your Clinical Trial.
The EU Clinical Trials Directive (and the future Clinical Trials Regulation) requires that the Sponsor, or their appointed representative, is legally established within the European Economic Area (EEA).
DLRC – Get Expertise and Experience on Your Side
DLRC Pharma Services is experienced in acting as an EU Legal Representative. We are able to advise on EU clinical trial requirements and provide oversight to ensure your study is authorised and conducted in accordance with EU legislation.
- Separating the Legal Representative and CRO roles allows independent regulatory oversight and continuity in the event of a change in CRO during the study
- Obtain independent expert advice on potential regulatory issues with the proposed study design or set-up
- A clear cost structure incorporating a fixed set-up cost for DLRC Pharma Services to conduct a risk assessment of the trial, and a monthly fee covering oversight of ongoing activities
- Avoid set up and on-going costs of establishing and maintaining an EU legal entity