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CLINICAL STUDIES MANAGEMENT

HALOPV TAKES THE HARD WORK OUT OF ACCELERATING, DESIGNING AND IMPLEMENTING PV PROCESSES.

Clinical Studies Management at a glance
  • Manage studies and make them available for the other modules to deliver study-centric

  • Auto-generate Investigator / Ethics Committee reporting for Submissions

Key features

  • Maintain information on audits, e.g. plan, execution, reporting, both internal as well as external, create assignable findings/observations records and generate CAPAs and CAPA reports automatically

  • Visualize actual CAPA effectiveness, if target process is also in HALOPV, e.g. observe number of process record tasks not timely in Complaints module in Sweden

  • Track audit deliverables and create tables and graphs of performance and e.g. findings per category

  • Managing QMS documents, schedule and perform training by individuals

  • Mange deviations / non-conformities and track timeliness

  • Manage training records for staff, including timeliness tracking