Study Managements

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Study Managements

Merc provides assistance with all activities related to the management of Clinical Studies:

  • Selection of study sites and Investigators, definition of  financial agreements.
  • Protocol and CRF design, in collaboration with the PI.
  • SOP definition and implementation in compliance with Regulatory requirements (ISO 14155 standards and Good Clinical Practice requirements).
  • Management of administrative issues (contacts with Authorities, insurance policies, document translation , budget control, etc.)
  • Reporting of adverse events.
  • Training of all participants (Investigators and Sites) and the GCP, in order to ensure compliance with Regulations.
  • Keeping investigators and sites up-to-date with the status and progress of the study.
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