Other Documents

  • Clinical development programmes require a range of documentation, regulatory as well as non-regulatory, all of which Trilogy can provide.
  • Having writers from Trilogy involved from the early stages (e.g. preparing Clinical Development Plans, International Medicinal Product Dossiers or Investigational New Drug applications) means that thoughts and messages are clearly structured and presented from the beginning, which streamlines the writing of all later documents.
  • Utilizing a Trilogy dedicated team to prepare not only the main regulatory documents, but also supportive regulatory documents (e.g. subject narratives, Informed Consent Forms, Risk Management Plans, Periodic Safety Update Reports,) and documents based on information originating from regulatory documents (e.g. manuscripts, posters) ensures consistency and continuity – making the overall writing process more efficient.
  • All documents benefit from having been prepared by a professional writer.