Services

 

Acadustri Limited operates from a Surrey-based office, however, Justina makes regular visits to client sites depending on the nature of the project. Justina also works closely with the client’s interdisciplinary team and has regular contact by email and conference calls. Justina imbues the company with expertise in preparing the following range of documents:

Clinical Reports, Pharmacovigilance Reports, Academic Manuscripts, Patient Support Materials

Clinical Reports
  • Clinical study reports for phase I-IV trials to ICH guidelines
  • Investigator’s brochures
  • Study protocols & amendments
  • Regulatory submission documents (CTD modules)

Pharmacovigilance Reports
  • Periodic Safety Update Reports
  • Annual Safety Reports
  • Risk-Benefit assessments
  • Risk Management Plans
  • Safety summaries
  • SAE narratives

Academic Manuscripts
  • Scientific manuscripts for publication in peer-reviewed journals
  • Book chapters
  • Literature reviews

Patient Support Materials
  • Patient information leaflets
  • Informed consent forms