Enabling non-EU sponsors to perform clinical research in the European Union.
The EU Clinical Trials Directive (Directive 2001/20/EC) was published on 4 April 2001 and all EU member states have now incorporated these provisions into national legislation.
This directive sets the legal framework for harmonising national laws and has created one of the largest potential opportunities for clinical research in the world. The legislation is based on Good Clinical Practice and aims to standardise the procedures and improve communication within the 28 member states. Article 19 of the Directive requires any Sponsor who is established outside of the EU (i.e. without a registered address in the EU) must have a Legal Representative, established within the EU.
I.D.E.A. Ltd. fulfils the requirement for Legal Representation specified in Article 19 of the Clinical Trials Directive and will help you to understand and comply with European regulations. We can provide a range of additional services to support your clinical, regulatory and project management needs in the EU.