Clinical Trial Application Dossier

  • A clinical trial application dossier is presented to a Regulatory Agency within a Member State of the European Union, as the basis for authorisation of a clinical trial, as required by EU Regulation 536/2014.
  • The dossier itself comprises the completed clinical trial application form, together with the relevant associated documents: Investigational Medicinal Product Dossier (IMPD), Summary of Product Characteristics (SmPC), study protocol and Investigator’s Brochure (IB).
  • Trilogy can advise on your documentation needs and offers the scientific expertise and industry experience required to provide the full range of documentation required for your trial application.