DURING THE STUDY

• 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