IMPDs are submitted as part of the Clinical Trial Application Dossier, as the basis for approval of clinical trials by competent regulatory authorities within the European Union. Investigational New Drug (IND) applications are the equivalent in the United States.
Utilizing a Trilogy dedicated team to prepare not only the initial trial applications, but also subsequent trial documentation (e.g. protocols, Informed Consent Forms, Investigator’s Brochures, study reports, subject narratives, Risk Management Plans, Periodic Safety Update Reports, etc.) ensures consistency and continuity – making the overall writing process more efficient – and the conclusions much clearer.