Responsibilities
Under the terms of article 19 of the EU Directive 2001/20/EC, sponsors not established in the EU are required to have a legal representative in the EU. There are many obligations for sponsors including reporting to ECs and CAs and adverse event recording and reporting.
The Legal Representative takes on the role of the Sponsor within the EU including the responsibilities of the Sponsor with regards to GCP, GMP and regulatory compliance. I.D.E.A Ltd takes this role seriously and our expert team works closely with the Sponsor to ensure compliance with all relevant EU Directives and National Legislation.
The Sponsor Representative service
Article 3 of the EU Directive states that the sponsor should have liability insurance for the performance of studies in Europe.
I.D.E.A. Ltd. can assist you in selecting an appropriate insurance provider to ensure you have the necessary cover for your trial in all EU Member States. I.D.E.A. Ltd. can recommend multiple insurance companies that have been preselected because of their conditions and experience in the area of liability, product insurance, and volunteer/ patient insurance.
The Competent Authorities
The Competent Authorities may perform random audits to assess compliance of the trial with the standards of GMP and GCP.
I.D.E.A. Ltd can help guide you through these audits to assure the best possible results.