STUDY MANAGEMENT

Qualified and senior study managers ensure efficient coordination and reporting of your national or multinational study. We provide complete planning, coordination and control of resources, timelines, communication, costs, and quality as well a detailed risk management plans, through the following activities.

  • Professional management of communications and client relationship
  • Definition and control of timelines and budgets
  • Efficient management and coordination of the study  team
  • Contribution to the content of key trial documents such as protocol, patient information and informed consent form, case report form
  • Development and execution of appropriate project-related plans: communication plan, recruitment plan, quality control plan and risk management plan to guarantee the smoother project conduction and completion
  • Management of contractual issues with investigators and hospitals
  • Organization of Investigator’s Meetings
  • Set-up and maintenance of study specific CTMS
  • Management of day-to-day operational aspects in relation to management of Country Study Managers/Site Monitors, organization of trainings and presentations, subjects’ recruitment, tracking  of drug supply, data flow and collection, safety reporting, trial supply logistics, preparation of newsletters
  • Revision of project plans as appropriate to meet changing needs
  • Preparation of weekly/monthly study status reports to the sponsor
  • Set-up and maintenance of study eTMF
  • Cooperation with RBM manager, data manager, statistician, and Pharmacovigilance Manager
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