Drop Down MenusCSS Drop Down MenuPure CSS Dropdown Menu


  • maintaining Investigators' Site Files and Trial Master Files and providing standardized documents required before, during and after the study
  • developing study-specific forms, depending on the specific study design and objectives
  • help in site visits, any interim meetings, Q&A logs
  • medical writing of clinical study protocols, Investigator's Brochures, safety summaries or case narratives/listings
  • processing all kinds of safety reports (from initial SAE narratives on a site-level to CIOMS/MedWatch notifications) on an expedited basis
  • amendments, informed consent updates, Investgator's Brochure updates, DSUR/PSUR updates
  • document packages required for endpoint adjudication
  • assisting during site audits
  • processing any correspondence with Ethics Committees, including their composition and policies