Explore: Biological Licence Application (BLA) | Clinical Trial Application Dossier | Narratives | New Drug Application (NDA) | Pregnancy Prevention Plan (or Programme, PPP) | Product Information (PI) | Statistical Analysis Plan (SAP) | Summary of Product Characteristics (SmPC) | United States Prescribing Information (USPI)

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.