Central Management of Large International Studies

To cope with the numerous challenges associated with international trial management, all IST project managers have highly developed motivational and personal communication skills, and apply a team-oriented approach to trial management.

Risk-based management strategies and technologies are used to deliver superior services saving time and money across all levels of study operation.

 

  • Briefing of national study units
  • Feasibility questionnaires
  • Production of documentation-material and logistics
  • CRF handling instructions, annotated CRFs, trial guidelines, project-specific SOPs
  • Interaction of third parties (central laboratories, randomization centers, logistic centers, local CROs)
  • Kick-off meetings and training of national staff
  • Documentation lists and tracking tools
  • Check of milestones and deadlines
  • Performance reports
  • Regular telephone conferences
  • Conference minutes, newsletters and reports on study status, study-material logistics
  • Early warning concept and risk management
  • Query management
  • Process optimization
  • Logistics of interim analyses
  • Science-review logistics
  • Essential-study documents logistics
  • Support of national units during study-site close-down
  • Management of trial master file
  • Support of national units with audits and inspections
  • News letters
  • Monitoring guidelines/plans
  • Assistance in preparation of study reports and publication manuscripts
  • Project-specific manuals
  • Deliverables and responsibilities
  • Training of project team
  • Communication plans