Clinical Trial Applications
When performed for the purpose of a European Marketing Authorization Application, all Clinical Trials have to be performed in compliance with Directive 2001/20/EC and Regulation 536/2014/EC. This Directive also provides approval requirements and the content of the Application “package” for all Clinical Trials performed in at least one of the Member States of the European Economic Area. It is, however, a fact that the ratifying national legislation can differ in minor but various aspects across the member states.
AccepTher reviews all elements of the Clinical Trial Application “package” required European Competent Authorities and assumes its submission with an assurance that avoidable delays are indeed avoided. If required we also assume to write elements of the CTA.
If a pivotal study for European registration is targeted, provisions of the Clinical Trial Directive and Regulation should be respected also when outsourcing a study to CRO based in a third country, which is often a choice for Sponsors hoping for limited requirements on approval documentation, shorter approval times and/or cheaper service.
AccepTher provides experienced support to companies wishing to sponsor trials outside the European Union to maximize benefits, and minimize risks; click here for more.